ClinicalTrials.gg
RecruitingNCT07269379ERO-CARDUpdated Dec 8, 2025

Intradialytic Exercise With Blood Flow Restriction in Hemodialysis Patients

An interventional study of Chronic phase - HDEX/HDBFRE and Acute phase - HDEX/HDBFRE in Dialysis Patients, sponsored by University of Avignon. Recruiting at 2 sites in France. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-12-08.

Sponsored by University of Avignon · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Nov 2025; still recruiting 1 year later.
Phase
Not applicable
Study type
Interventional
Enrollment
108
Allocation
Randomized
Ages
20 Years to 79 Years
Sex
All
01

Study summary

The main objective is to evaluate in hemodialysis patients the effects of two intradialytic rehabilitation programs based on physical exercise, with or without the application of blood flow restriction, on myocardial stunning and morpho-functional cardiac remodelling, compared with usual care (i.e., dialysis without exercise). In addition, the investigators will also assess the acute effects (i.e., a single session for each condition) of physical exercise, with or without blood flow restriction, on myocardial stunning at the end of dialysis.

In comparison with a conventional exercise program, the combination of physical exercise with blood flow restriction, which synergistically and additively activates intramuscular signalling pathways related to both exercise and ischaemia, is hypothesised to result in:

  1. A greater intradialytic cardioprotection, as demonstrated by a greater reduction in myocardial stunning at the end of dialysis (both in acute and chronic applications), with underlying mechanisms involving systemic and neuro-humoral pathways;
  2. Significant improvements in morpho-functional cardiac remodelling, attenuation of arrhythmic disturbances, and enhancement of aerobic capacity, muscle strength, and muscle mass-effects not observed with exercise alone without blood flow restriction, considering the low exercise intensity used in the current rehabilitation program (chronic application only).

This is a three-arm randomised clinical trial with parallel groups: standard hemodialysis (HD-CONTChro), a rehabilitation program with intradialytic exercise without vascular occlusion (HD-EXChro), and a rehabilitation program with intradialytic exercise with vascular occlusion (HD-BFREChro), with a 1:1:1 allocation ratio.

To investigate the acute effects of the interventions, all patients will undergo, in a randomized order, one session of each of the three dialysis modalities-standard hemodialysis (HD-CONTacute), hemodialysis with exercise without vascular restriction (HD-EXacute), and hemodialysis with exercise with vascular restriction (HD-BFREacute)-prior to initiation of the chronic phase of the study.

02

Conditions studied

  • Dialysis Patients

Keywords

  • end stage renal disease
  • hemodialysis
  • blood flow restriction exercise
  • intradialytic exercise
  • regional myocardial function
  • hemorheology
03

In context

Kidney Failure, Chronic

2,108 studies on the registry are indexed under Kidney Failure, Chronic; 273 are open to participants now.

This study's planned enrollment of 108 is above the median of 57 across 1,569 interventional studies indexed under Kidney Failure, Chronic.

Browse Kidney Failure, Chronic studies →

Lead sponsor

University of Avignon is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged between 20 and 79 years.
  • Patients on hemodialysis for more than 3 months.
  • No engagement in regular exercise outside of dialysis.
  • No prior exposure to intradialytic exercise within the past six months.
  • No medical to physical activity.
  • greater than 6 months.
  • Patients with relative good echogenicity

Exclusion criteria

Exclusion Criteria:

  • Patient is participating in another Category I interventional study, or has participated in another interventional study within the past 3 months
  • The patient is in an exclusion period determined by a previous study
  • The patient is under legal protection or under guardianship or curatorship It turns out to be impossible to give the patient informed information, or the patient refuses to sign the consent
  • Pregnant, parturient or breastfeeding patient
  • Patients with unstable coronary artery disease.
  • Patients with peripheral artery disease (stage III or IV) in the lower limbs.
  • Patients with limb amputation.
  • Patients with musculoskeletal disorders impairing exercise.
  • Presence of a pacemaker, cardiac stimulation device, or implantable cardioverter defibrillator (ICD).
  • History of heart transplant.
  • Patients with uncontrolled hypertension.
  • anemia.
  • Patients stratified as high risk for deep venous thrombosis
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
108 participants (estimated)

Study arms

  • Experimental
    Experimental: HD-EXChro

    Will be enrolled in a 12 weeks intradialytic exercise program without vascular occlusion

    Other: Chronic phase - HDEX/HDBFRE · Other: Acute phase - HDEX/HDBFRE

  • Experimental
    Experimental: HD-BFREChro

    Will be enrolled in a 12 weeks intradialytic exercise program with vascular occlusion

    Other: Chronic phase - HDEX/HDBFRE · Other: Acute phase - HDEX/HDBFRE

  • No intervention
    Control

    Patients with standard HD (usual care)

Interventions

  • OtherChronic phase - HDEX/HDBFRE

    30 min of intradialytic cycling at a moderate intensity (12-14) , starting 30min after HD onset. 3 times a week for 12 weeks. No vascular occlusion for HDEXChro. Pressure at 50% of limb occlusion pressure on both legs for HDBFREChro

  • OtherAcute phase - HDEX/HDBFRE

    30 min of intradialytic cycling at a moderate intensity (12-14) , starting 30min after HD onset. No vascular occlusion for HDEXacute. Pressure at 50% of limb occlusion pressure on both legs for HDBFREacute

06

What researchers measure

Primary outcomes

  1. Change in the number of regional wall motion abnormalities (RWMAs)

    The investigators will use echocardiography to assess the number of left ventricular myocardial segments (using a 18-segment model), that demonstrate a reduction in longitudinal deformation greater than 20% at peak stress during hemodialysis, relative to baseline measurements obtained at the start of the dialysis session. Their aim is to compare the change in regional wall motion abnormalities (RWMAs) at peak stress of dialysis (i.e. 30 min before its end), in a standard HD, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). For the acute phase, the investigators will compare the number of RWMAs measured 30min before the end of each HD session between the 3 conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

Secondary outcomes

  1. Change in LV longitudinal strains

    Using speckle tracking echocardiography, the investigators will assess variations in LV longitudinal strains during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Strains (in %) measure the amount of myocardial longitudinal shortening of the cavity, are relatively load-independent, and can detect subclinical myocardial dysfunction, even when it is not apparent by conventional echocardiography. For the acute phase, the investigators will compare the changes in left ventricular (LV) longitudinal strain kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  2. Change in RV longitudinal strains

    Using speckle tracking echocardiography, the investigators will assess variations in RV longitudinal strains during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Strains (in %) measure the amount of myocardial longitudinal shortening of the cavity, are relatively load-independent, and can detect subclinical myocardial dysfunction, even when it is not apparent by conventional echocardiography. For the acute phase, the investigators will compare the changes in right ventricular (RV) longitudinal strain kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  3. Change in LA longitudinal strains

    Using speckle tracking echocardiography, the investigators will assess variations in LA longitudinal strains during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Strains (in %) measure the amount of myocardial longitudinal shortening of the cavity, are relatively load-independent, and can detect subclinical myocardial dysfunction, even when it is not apparent by conventional echocardiography. For the acute phase, the investigators will compare the changes in left atrial (LA) longitudinal strain kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  4. Change in global constructive work

    The investigators will assess variations in global constructive work during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Global constructive work (GCW, expressed in mmHg%) will be measured using speckle-tracking echocardiography from the pressure-longitudinal strain loop generated with the dedicated module provided by the ultrasound vendor. GCW represents the work performed during shortening in systole adding negative work during lengthening in isovolumetric relaxation. For the acute phase, the investigators will compare the changes in LV global constructive work kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  5. Change in global wasted work

    The investigators will assess variations in global wasted work during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Global wasted work (GWW, expressed in mmHg%) will be measured using speckle-tracking echocardiography from the pressure-longitudinal strain loop generated with the dedicated module provided by the ultrasound vendor. GWW represents the negative work performed during lengthening in systole adding work performed during shortening in isovolumetric relaxation. For the acute phase, the investigators will compare the changes in LV global wasted work kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  6. Change in global work efficiency

    The investigators will assess variations in global work efficiency during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Global work efficiency (GWE, expressed in %) will be measured using speckle-tracking echocardiography from the pressure-longitudinal strain loop generated with the dedicated module provided by the ultrasound vendor. GWE will be calculated as follow: Global constructive work divided by the sum of global constructive and wasted work. For the acute phase, the investigators will compare the changes in LV global work efficiency kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  7. Change in global myocardial work

    The investigators will assess variations in global myocardial work during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Global myocardial work (GMM, expressed in %) will be measured using speckle-tracking echocardiography from the pressure-longitudinal strain loop generated with the dedicated module provided by the ultrasound vendor. GMM represents the area of the Longitudinal strain-pressure loop. For the acute phase, the investigators will compare the changes in LV global myocardial work kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  8. Change in left intraventricular pressure gradient

    The investigators will assess variations in the left intraventricular pressure gradient, measured by postprocessing color Doppler M-mode echocardiographic images during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). For the acute phase, the investigators will compare the changes in LV intraventricular pressure gradient kinetics throughout dialysis (e.g., from the start to 30 minutes before the end of hemodialysis) among the three sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  9. Change in LV diameter

    The investigators will assess variations in left ventricular (LV) diameter at end-systole and end-diastole, measured using Doppler M-mode echocardiography, before a standard dialysis session, before and after the 12-week program. (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).

    Time frame: From enrollment to the end of the program at 19 weeks

  10. Change in LV wall thicknessess

    The investigators will assess variations in the LV wall thicknessess, measured by Doppler M-mode echocardiographic images before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).

    Time frame: From enrollment to the end of the program at 19 weeks

  11. Change in LV volumes

    The investigators will assess variations in left ventricular (LV) volumes at end-systole and end-diastole, measured using echocardiography before a standard dialysis session, before and after the 12-week program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).

    Time frame: From enrollment to the end of the program at 19 weeks

  12. Change in LV mass

    The investigators will assess variations in the LV mass measured using echocardiography before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV morphology of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  13. Change in LV global systolic function (ejection fraction)

    The investigators will assess variations in the LV ejection fraction measured using echocardiography before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV global systolic function of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  14. Change in LV s' wave

    The investigators will assess variations in the LV s' wave measured by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV regional function of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  15. Change in LV e' wave

    The investigators will assess variations in the LV e' wave measured by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV regional diastolic function of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  16. Change in LV a' wave

    The investigators will assess variations in the LV a' wave measured by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV regional diastolic function of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  17. Change in LV E wave (global diastolic function)

    The investigators will assess variations in the LV E wave measured by pulsed Doppler ehocardiography during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). For the acute phase, the investigators will compare the change in LV E wave throughout the dialysis (eg before and 30min before the end of each HD) between 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute). LV E is an index of global diastolic function, characterising the LV early filling.

    Time frame: From enrollment to the end of the program at 19 weeks

  18. Change in LV A wave (global diastolic function)

    The investigators will assess variations in the LV A wave measured by pulsed Doppler ehocardiography during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). For the acute phase, the investigators will compare the change in LV A wave throughout the dialysis (eg before and 30min before the end of each HD) between 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute). LV A is an index of global diastolic function, characterising the LV late filling.

    Time frame: From enrollment to the end of the program at 19 weeks

  19. Change in LV E/e'

    The investigators will assess variations in the LV E/e' ratio measured before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LV filling pressure of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  20. Change in RV areas

    The investigators will assess variations in the RV area at end-systole and end-diastole measured before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the RV morphology and function of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  21. Change in RV systolic function

    The investigators will assess variations in the RV fractional area measured using echocardiography before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the RV global systolic function of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  22. Change in RV systolic function 2

    The investigators will assess variations in the Tricuspid Annular Plane Systolic Excursion measured using echocardiography before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the RV global systolic function of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  23. Change in RV areas

    The investigators will assess variations in the RV area at end-systole and end-diastole before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the RV morphology and function of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  24. Change in RV diameter

    The investigators will assess variations in the RV diameter and end-systole and end-diastole, measured by Doppler M-mode echocardiographic images before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro).

    Time frame: From enrollment to the end of the program at 19 weeks

  25. Change in RV Et wave

    The investigators will assess variations in the RV Et wave by pulsed Doppler ehocardiography images before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV global diastolic function.

    Time frame: From enrollment to the end of the program at 19 weeks

  26. Change in RV At wave

    The investigators will assess variations in the RV At wave by pulsed Doppler ehocardiography images before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV global diastolic function.

    Time frame: From enrollment to the end of the program at 19 weeks

  27. Change in RV Et/At ratio

    The investigators will assess variations in the RV Et/At ratio before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV global diastolic function.

    Time frame: From enrollment to the end of the program at 19 weeks

  28. Change in RV e'

    The investigators will assess variations in the RV e' wave by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV regional diastolic function.

    Time frame: From enrollment to the end of the program at 19 weeks

  29. Change in RV a'

    The investigators will assess variations in the RV a' wave by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV regional diastolic function.

    Time frame: From enrollment to the end of the program at 19 weeks

  30. Change in RV s'

    The investigators will assess variations in the RV s' wave by tissue Doppler imaging before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize RV regional systolic function.

    Time frame: From enrollment to the end of the program at 19 weeks

  31. Change in tricuspid regurgitation

    The investigators will assess variations in the tricuspid regurgitation by continuous-wave Doppler ehocardiography before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). It will be used to characterize LV global diastolic function.

    Time frame: From enrollment to the end of the program at 19 weeks

  32. Change in RV Et/e'

    The investigators will assess variations in the RV Et/e' ratio before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the RV filling pressure of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  33. Change in LA morphology and function

    The investigators will assess variations in the LA volumes measured before and at end of a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the LA morphology and function of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  34. Change in blood pressure

    The investigators will measure blood pressure every 30min during a standard dialysis (i.e. from the beginning to the end of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Their aim is to compare the changes during HD among the three groups. For the acute phase, the investigators will compare the change in blood pressure every 30min from the beginning to the end of HD across the three experimental conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  35. Change in cardiac output

    The investigators will measure cardiac output every 30min during a standard dialysis (i.e. from the beginning to the end of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Their aim is to compare the changes during HD among the three groups. For the acute phase, the investigators will compare the change in cardiac output every 30min from the beginning to the end of HD across the three experimental conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  36. Change in stroke volume

    The investigators will measure stroke volume every 30min during a standard dialysis (i.e. from the beginning to the end of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Their aim is to compare the changes during HD among the three groups. For the acute phase, the investigators will compare the change in stroke volume every 30min from the beginning to the end of HD across the three experimental conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  37. Change in heart rate

    The investigators will measure heart rate every 30min during a standard dialysis (i.e. from the beginning to the end of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). Their aim is to compare the changes during HD among the three groups. For the acute phase, the investigators will compare the change in heart rate every 30min from the beginning to the end of HD across the three experimental conditions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  38. Change in blood level of sodium

    The investigators will assess variations in blood level of sodium before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  39. Change in blood level of potassium

    The investigators will assess variations in blood level of potassium before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  40. Change in blood level of calcium

    The investigators will assess variations in blood level of calcium before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  41. Change in blood level of phosphate

    The investigators will assess variations in blood level of phosphate before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  42. Change in blood level of vitamin D

    The investigators will assess variations in blood level of vitamin D before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  43. Change in blood level of parathyroid hormone

    The investigators will assess variations in blood level of parathyroid hormone before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  44. Change in blood level of creatinine

    The investigators will assess variations in blood level of creatinine before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  45. Change in creatinine clearance

    The investigators will assess variations in creatinine clearance before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  46. Change in blood level of urea

    The investigators will assess variations in blood level of urea before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  47. Change in serum level of albumin

    The investigators will assess variations in serum level of albumin before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  48. Change in normalized proteïn catabolic rate

    The investigators will assess variations in normalized proteïn catabolic rate before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  49. Change in Kt/V

    The investigators will assess variations in Kt/V before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients.

    Time frame: From enrollment to the end of the program at 19 weeks

  50. Change in serum level of c-reactive protein

    The investigators will assess variations in serum level of c-reactive protein before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the progression of disease of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  51. Change in complete blood count

    The investigators will assess variations in complete blood count before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the blood of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  52. Change in serum level of ferritin

    The investigators will assess variations in serum level of ferritin before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the blood of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  53. Change in transferrin saturation

    The investigators will assess variations in transferrine saturation before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the blood of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  54. Change in LDL cholesterol

    The investigators will assess variations in LDL cholesterol before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the lipidic profile of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  55. Change in HDL cholesterol

    The investigators will assess variations in HDL cholesterol before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the lipidic profile of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  56. Change in triglyceride level

    The investigators will assess variations in triglyceride level before a standard dialysis, before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). This will be used to characterize the lipidic profile of the patients. A blood sample will be taken directly from the arterial line of the dialysis machine at the onset of dialysis.

    Time frame: From enrollment to the end of the program at 19 weeks

  57. Change in hematocrit

    The investigators will assess variations in hematocrit, measured using an hemoglobinometer, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in hematocrit kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  58. Change in hemoglobin level

    The investigators will assess variations in hemoglobin, measured using an hemoglobinometer, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in hemoglobin kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  59. Change in interleukin-6 level

    The investigators will assess variations in interleukin-6 level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in interleukin-6 kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  60. Change in interleukin-10 level

    The investigators will assess variations in interleukin-10 level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in interleukin-10 kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  61. Change in tumor necrosis factor-α level

    The investigators will assess variations in tumor necrosis factor-α level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in tumor necrosis factor-α kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  62. Change in ultra-sensitive c-reactive protein level

    The investigators will assess variations in ultra-sensitive c-reactive protein level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in C-reactive protein kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  63. Change in intercellular adhesion molecule-1 level

    The investigators will assess variations in intercellular adhesion molecule-1 level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in intercellular adhesion molecule-1 level kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  64. Change in vascular cell adhesion molecule-1 level

    The investigators will assess variations in vascular cell adhesion molecule-1 level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in vascular cell adhesion molecule-1 kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  65. Change in endothelin level

    The investigators will assess variations in endothelin level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in endothelin kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  66. Change in proendothelin level

    The investigators will assess variations in proendothelin level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in pro-endothelin kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  67. Change in NT-pro-BNP level

    The investigators will assess variations in NT-pro-BNP level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in NT-pro-BNPkinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  68. Change in BNP level

    The investigators will assess variations in BNP level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in BNP kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  69. Change in cardiac troponin T level

    The investigators will assess variations in cardiac troponin T level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in cardiac troponin T kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  70. Change in levels of soluble ST2

    The investigators will assess variations in levels of soluble ST2, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in soluble ST2 kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  71. Change in beta2-microglobulin level

    The investigators will assess variations in beta2-microglobulin level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in beta2-microglobulin kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  72. Change in indoxyl sulfate level

    The investigators will assess variations in indoxyl sulfate level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in indoxyl sulfate kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  73. Change in p-Cresyl sulfate level

    The investigators will assess variations in p-Cresyl sulfate level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in p-cresyl sulfate kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  74. Change in myoglobin level

    The investigators will assess variations in myoglobin level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in myoglobin kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  75. Change in free light chains

    The investigators will assess variations in cardiac free light chains, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in cardiac free light chain kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  76. Change in whole blood viscosity

    The investigators will assess variations in whole blood viscosity, measured using a cone-plate viscometer, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in whole blood viscosity kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  77. Change in erythrocyte deformability

    The investigators will assess variations in erythrocyte deformability, measured using an ektacytometer, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in erythrocyte deformability kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  78. Change in erythrocyte aggregation

    The investigators will assess variations in erythrocyte aggregation, measured using an ektacytometer, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in erythrocyte aggregation kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  79. Change in fibrinogen level

    The investigators will assess variations in fibrinogen level, measured by analyzing blood sample, during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in fibrinogen kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

  80. Change in miRNA

    The investigators will assess variations in levels of circulating mi-RNAs, quantified by reverse transcription-quantitative polymerase chain reaction (RT-qPCR), during a standard dialysis (i.e. from before to the peak stress of dialysis) before and after 12 weeks of program (for HD-EXChro and HD-BFREChro) or usual care (for HD-CONTChro). A blood sample will be taken directly from the arterial line of the dialysis machine immediately at the onset and at the end of dialysis. For the acute phase, the investigators will compare the change in circulating miRNA kinetics (from the start to 30min before the end of HD) between the 3 randomized sessions (i.e. HD-CONTacute, HD-EXacute, HD-BFREacute)

    Time frame: From enrollment to the end of the program at 19 weeks

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07269379
Lead sponsor
University of Avignon
Collaborators
Médipôle Lyon-Villeurbanne, Nouvel Hôpital Civil, 1 place de l'Hôpital 67091 Strasbourg cedex
Responsible party
Sponsor
First posted
Dec 8, 2025
Start date
Nov 6, 2025
Primary completion
May 6, 2028 (estimated)
Completion
Oct 6, 2028 (estimated)
Last update
Dec 8, 2025

Study contacts

Philippe Obert, PhD
Contact
philippe.obert@univ-avignon.fr
0033698050446
Nans Florens, PhD
principal investigator · CHU Strasbourg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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