Dapagliflozin's short-term effects on kidney and heart function in people with advanced heart failure on the transplant waiting list

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults (18–85) with advanced heart failure (NYHA class ≥3, LVEF ≤35%) who are on guideline-directed medical therapy including dapagliflozin and listed for heart transplantation will be enrolled at several French university hospitals. Participants will provide biological samples for measurement of suPAR and related markers to characterize acute reno-cardiac effects while on dapagliflozin. The protocol focuses on patients expected to remain on the transplant list for at least six months and collects clinical and laboratory data alongside the biomarker sampling. Results will compare biomarker patterns to better understand kidney–heart interactions in this high-risk population.

Why it matters

Who can join: the full rules

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)

Where it's running

• Chru Nancy
  Vandœuvre-lès-Nancy, France Recruiting
• Hospice Civil de Lyon - Hôpital Louis PRADEL
  Bron, France Not yet recruiting
• CHU Grenoble
  La Tronche, France Not yet recruiting
• CHU Montpellier
  Montpellier, France Not yet recruiting
• Chu Nantes
  Nantes, France Not yet recruiting
• Aphp Hegp
  Paris, France Not yet recruiting

Study contacts

• Study coordinator: Guillaume BAUDRY, MD
• Email: g.baudry@chru-nancy.fr
• Phone: +33 (0) 383157322

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.