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CompletedNCT03749551TRUE-TypeCKDUpdated Jan 6, 2026

Towards Understanding the Phenotype of Cardiovascular Disease in CKD - TRUE-Type-CKD Study

An observational study in Heart Failure, Cardiomyopathies and Chronic Kidney Diseases, sponsored by Johann Wolfgang Goethe University Hospital. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-06.

Sponsored by Johann Wolfgang Goethe University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
276
Ages
18 Years and older
Sex
All
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Study summary

Premature cardiovascular disease (CVD) is the leading cause of death in patients with kidney disease (CKD). Excessive cardiac mortality is thought to be secondary to non-atherosclerotic processes, with left ventricular (LV) hypertrophy (LVH) and remodelling being the predominant phenotypical features. Along with other risk factors, subclinical ischaemia and haemodynamic perturbations associated with haemodialysis (HD) are thought to contribute to the ultimate development of LV systolic and diastolic dysfunction. The development of these adverse features reflects a specific cardiomyopathy due to CKD and subsequently, to uraemia. Patients receiving hemodialysis (HD) have a higher incidence rate of heart failure (predominantly with preserved ejection fraction), with phenotypically eccentric hypertrophic remodelling, systolic and diastolic dysfunction as well as high rate of interstitial myocardial fibrosis. Detection and ultimately reversal of the development of this CKD-related cardiomyopathy are important goals for improving the CVD, morbidity and mortality of CKD patients.The objectives of this study are, firstly, to investigate the complex myocardial phenotype in patients with various stages of CKD, secondly, to relate the CMR-measures to outcome, and thirdly, to be able to estimate the effects of chronic uremia/hypervolemia. Deciphering the predominant driver of remodelling on an individual level may help to personalise anti-remodelling strategies. Native T1 and T2 mapping imaging provide non-invasive imaging tools to detect myocardial fibrosis and oedema, respectively. Prognostic associations of these measures may clarify the relative prevalence of adverse phenotype and their relative contribution to adverse events and poor outcome. The role of chronic water retention and uraemia may be associated with interstitial myocardial oedema promoting further the remodelling process.

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Conditions studied

  • Heart Failure
  • Cardiomyopathies
  • Chronic Kidney Diseases
  • Hypertrophy, Left Ventricular
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In context

Heart Failure

6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.

This study's enrollment of 276 is above the median of 200 across 1,983 observational studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

Johann Wolfgang Goethe University Hospital is the lead sponsor of 160 studies on the registry; 8 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
Probability sample

Study population

patients with established diagnosis of chronic kidney disease

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

  1. Adults >18 years of age
  2. Able to provide
  3. Chronic kidney disease stages G3-5 (\<59 ml/min/1.73m2)

Exclusion criteria

Exclusion Criteria:

  1. Absence of absolute clinical indication for MRI studies (MR unsafe or incompatible devices, aneurysm clips, cochlear implants, loose metal foreign objects)
  2. Absolute to gadolinium contrast agent (previous allergic reaction or pregnancy),
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.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

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.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
276 participants (actual)
Patient registry
No

Groups and cohorts

  • Participants

    diagnostic test - patients serving as their own controls

    Diagnostic Test: cardiac magnetic resonance (CMR) post haemodialysis

Interventions

  • Diagnostic testcardiac magnetic resonance (CMR) post haemodialysis

    patients will undergo a second CMR scan immediately after receiving haemodialysis (native CMR study)

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What researchers measure

Primary outcomes

  1. survival

    number of deaths

    Time frame: 1 year

  2. survival

    number of deaths

    Time frame: 5 year

  3. rate of death due to cardiovascular causes

    number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure

    Time frame: 1 year

  4. rate of death due to cardiovascular causes

    number of participants died due to death due to myocardial infarction, sudden cardiac death, heart failure

    Time frame: 5 year

Secondary outcomes

  1. rate of heart failure events

    number of participants with heart failure death and hospitalisation due to heart failure

    Time frame: 1 year

  2. rate of heart failure events

    number of participants with heart failure death and hospitalisation due to heart failure

    Time frame: 5 year

Other outcomes

  1. Change in native T1 and T2 (in msec) pre and post haemodialysis

    measurement of change in magnetisation relaxation (in msec)

    Time frame: 24 hour

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Study locations

1 site
  • University Hospital Frankfurt
    Frankfurt am Main, Hesse Frankfurt am Main, Germany
08

References and documents

Publications

  • Arcari L, Engel J, Freiwald T, Zhou H, Zainal H, Gawor M, Buettner S, Geiger H, Hauser I, Nagel E, Puntmann VO. Cardiac biomarkers in chronic kidney disease are independently associated with myocardial edema and diffuse fibrosis by cardiovascular magnetic resonance. J Cardiovasc Magn Reson. 2021 Jun 7;23(1):71. doi: 10.1186/s12968-021-00762-z. PubMed 34092229 ↗
  • Valbuena-Lopez SC, Camastra G, Cacciotti L, Nagel E, Puntmann VO, Arcari L. Cardiac Imaging Biomarkers in Chronic Kidney Disease. Biomolecules. 2023 Apr 29;13(5):773. doi: 10.3390/biom13050773. PubMed 37238643 ↗
  • Chen M, Arcari L, Engel J, Freiwald T, Platschek S, Zhou H, Zainal H, Buettner S, Zeiher AM, Geiger H, Hauser I, Nagel E, Puntmann VO. Aortic stiffness is independently associated with interstitial myocardial fibrosis by native T1 and accelerated in the presence of chronic kidney disease. Int J Cardiol Heart Vasc. 2019 Jun 26;24:100389. doi: 10.1016/j.ijcha.2019.100389. eCollection 2019 Sep. PubMed 31304234 ↗
  • Arcari L, Hinojar R, Engel J, Freiwald T, Platschek S, Zainal H, Zhou H, Vasquez M, Keller T, Rolf A, Geiger H, Hauser I, Vogl TJ, Zeiher AM, Volpe M, Nagel E, Puntmann VO. Native T1 and T2 provide distinctive signatures in hypertrophic cardiac conditions - Comparison of uremic, hypertensive and hypertrophic cardiomyopathy. Int J Cardiol. 2020 May 1;306:102-108. doi: 10.1016/j.ijcard.2020.03.002. Epub 2020 Mar 3. PubMed 32169347 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2018 to primary completion in Jun 2021, 38 months.

Of 793 non-industry observational studies under Heart Failure, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 99. This study's 38 months is below that.

Counting every sponsor, half of 975 studies reached it within 41 months; a quarter within 23 and three quarters within 89.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 17, 2018
First posted
Nov 21, 2018
StartActual
Mar 28, 2018
Primary completionActual
Jun 14, 2021
CompletionActual
Jun 14, 2021
Last update
Jan 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2026, 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
NCT03749551
Responsible party
Valentina Puentmann (Principal Investigator, Johann Wolfgang Goethe University Hospital) — Principal investigator
First posted
Nov 21, 2018
Start date
Mar 28, 2018
Primary completion
Jun 14, 2021
Completion
Jun 14, 2021
Last update
Jan 6, 2026

Oversight

Data monitoring committee
No
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 Jan 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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