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CompletedNCT04043871SFATI-IRCUpdated Dec 1, 2025

Concordance Between the Foot-to-Apex Systolic Interval and the Auscultatory Method for Measurement of Brachial Systolic Pressure in Patients With Severe Renal Failure

An observational study in Renal Insufficiency, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-01.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
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Study summary

The investigators hypothesize that the Systolic Foot-to-Apex Time Interval (SFATI) method will be accurate for measurement of systolic blood pressure with marked arterial stiffness as seen in patients with severe renal impairment. Also that the presence of arterial calcifications only changes the agreement between the SFATI method and the reference method (auscultatory method) if the calcifications are very severe.

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Conditions studied

  • Renal Insufficiency

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In context

Renal Insufficiency

1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.

This study's enrollment of 90 is below the median of 149 across 394 observational studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

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

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of patients with severe renal impairment (defined by a glomerular filtration rate \<30 mL / min, assessment within previous 3 months), stage 4 or stage 5.

Patients will be selected during consultations in the Nephrology department or during dialysis sessions at the University Hospital of Nîmes.

Inclusion criteria

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • Patient under consultation in the Nephrology for severe renal impairment (defined by a glomerular filtration rate \<30 mL / min, assessment within previous 3 months)

Exclusion criteria

Exclusion Criteria:

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient is pregnant or breastfeeding
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
90 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients with renal insufficiency

    Diagnostic Test: Systolic blood pressure

Interventions

  • Diagnostic testSystolic blood pressure

    Systolic blood pressure measured by Foot-to-Apex Systolic Interval, conventional oscillometric measurement, and the auscultatory method

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What researchers measure

Primary outcomes

  1. Systolic blood pressure according to oscillometric curve

    mmHg measured by Systolic Foot-to-Apex Time Interval

    Time frame: Day 0

  2. Systolic blood pressure according to Korotkov sounds

    mmHg measured by auscultatory method

    Time frame: Day 0

Secondary outcomes

  1. Brachial pulse wave velocity

    m/s

    Time frame: Day 0

  2. Systolic blood pressure according to conventional oscillometric measurement

    mmHg; Dinamap

    Time frame: Day 0

  3. Brachial artery calcium score

    Measured by ultrasound of the arteries of the upper limb

    Time frame: Day 0

  4. Presence of arterial rigidity

    Yes/No, measured by Complior \> 10 m/s

    Time frame: Day 0

  5. Disease-associated patient characteristics

    Age, sex, diabetes, Chronic Renal Disease stage

    Time frame: Day 0

  6. Modification of antihypertensive treatment to maintain systolic tension between 110 and 130 mm Hg

    Change in antihypertensive treatment following measurement

    Time frame: Day 0

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Study locations

1 site
  • CHU de Nimes
    Nîmes, 30029, France
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References and documents

Publications

  • Benmira AM, Moranne O, Prelipcean C, Pambrun E, Dauzat M, Demattei C, Perez-Martin A. Direct Determination rather than Oscillometric Estimation of Systolic Blood Pressure in Patients with Severe Chronic Kidney Disease. Am J Nephrol. 2022;53(1):41-49. doi: 10.1159/000520996. Epub 2022 Jan 12. PubMed 35021175 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04043871
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Collaborators
Technology Transfer Accelerator Offices _ SATT AxLR
Responsible party
Sponsor
First posted
Aug 2, 2019
Start date
Jun 5, 2019
Primary completion
Aug 14, 2019
Completion
Aug 14, 2019
Last update
Dec 1, 2025

Study contacts

Antonia Perez Martin
principal investigator · CHU Nimes

Oversight

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

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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