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New study tracks how common heart drug affects kidneys in transplant candidates

NCT ID NCT06868797

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 103 advanced heart failure patients on a transplant waiting list to see how dapagliflozin affects the link between heart and kidney health. Researchers will measure a protein called suPAR in the blood over 6 months to track kidney damage. The goal is to better understand how heart failure and kidney function interact in these patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dapagliflozin
What this could lead to
If successful, this could help doctors better understand and manage heart-kidney interactions in advanced heart failure patients.
What could go wrong
This is an observational study, not a treatment trial, so it won't prove dapagliflozin's effectiveness. Results may not apply to all heart failure patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 103 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years and ≤ 85 years 2. NYHA class ≥3 3. LVEF ≤ 35% 4. On GDMT (including dapagliflozin) based on current heart failure practice guidelines at maximal tolerated dose 5. On waiting list (or on the registration pathway) for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to heart transplant ≥ 6 months or in a pre-transplant pathway. 6. Person affiliated to a social security scheme or beneficiary of such a scheme. 7. A person who has received full information about the organization of the clinical research and has signed an informed consent form. Exclusion Criteria: 1. Priority patient on waiting list for heart transplantation. 2. Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy. 3. Inotrope dependent, existence of ongoing mechanical circulatory support 4. Current acute decompensated HF or hospitalization due to decompensated HF \<30 days prior to the enrolment. 5. History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after inclusion. 6. Any recent interventional procedure likely to improve symptoms and heart failure status (coronary revascularization, percutaneous mitral valve intervention, cardiac resynchronization therapy) \< 60 days. 7. Glomerular filtration rate \<25 ml/min/1.73 m2, according to CKD-EPI formula 8. Unstable or rapidly progressing renal disease (autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis). 9. Type 1 diabetes mellitus. 10. Participation in another clinical interventional trial. 11. Any condition other than heart failure that could limit survival to less than 12 months. 12. Pregnant women or breastfeeding mothers 13. vulnerable persons (guardianship, curatorship, safeguard of justice)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aphp Hegp

    NOT_YET_RECRUITING

    Paris, 75015, France

  • CHU Bordeaux

    NOT_YET_RECRUITING

    Pessac, 33600, France

  • CHU Grenoble

    NOT_YET_RECRUITING

    La Tronche, 38700, France

  • CHU Montpellier

    NOT_YET_RECRUITING

    Montpellier, 34295, France

  • CHU Rennes

    NOT_YET_RECRUITING

    Rennes, 35033, France

  • CHU Strasbourg

    NOT_YET_RECRUITING

    Strasbourg, 67091, France

  • CHU de Toulouse

    NOT_YET_RECRUITING

    Toulouse, 31059, France

  • Chru Nancy

    RECRUITING

    Vandœuvre-lès-Nancy, 54500, France

  • Chu Nantes

    NOT_YET_RECRUITING

    Nantes, 44093, France

  • Chu Rouen

    NOT_YET_RECRUITING

    Rouen, 76031, France

  • Hospice Civil de Lyon - Hôpital Louis PRADEL

    NOT_YET_RECRUITING

    Bron, 69500, France

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