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

Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List

This project will test whether dapagliflozin is linked with improved kidney and heart biomarkers in adults with advanced heart failure who are waiting for a heart transplant.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 103 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Central Hospital, Nancy, France (Academic / other)
• Locations: 11 sites (Bron and 10 other locations)
• Trial ID: NCT06868797 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–85 with advanced heart failure (NYHA ≥3, LVEF ≤35%) already on guideline-directed medical therapy including dapagliflozin and placed on a heart transplant waiting list with an expected wait of six months or more who can give informed consent.

Not a fit: Patients unlikely to benefit include those who are priority transplant candidates, are inotrope-dependent or on mechanical circulatory support, have acute decompensated heart failure, or have excluded causes such as amyloidosis or uncorrected thyroid or restrictive/pericardial cardiomyopathies.

Why it matters

Potential benefit: If successful, the findings could help clinicians understand whether dapagliflozin protects kidney function and supports heart stability in patients waiting for transplant, informing treatment decisions.

How similar studies have performed: SGLT2 inhibitors like dapagliflozin have shown heart and kidney benefits in large trials, but using suPAR to track acute reno-cardiac effects specifically in transplant-listed patients is a relatively novel approach.

Eligibility criteria

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 this trial is running

Bron and 10 other locations

• 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)
• CHU Bordeaux — Pessac, France (Not_yet_recruiting)
• CHU Rennes — Rennes, France (Not_yet_recruiting)
• Chu Rouen — Rouen, France (Not_yet_recruiting)
• CHU Strasbourg — Strasbourg, France (Not_yet_recruiting)
• CHU de Toulouse — Toulouse, France (Not_yet_recruiting)
• Chru Nancy — Vandœuvre-lès-Nancy, France (Recruiting)

Study contacts

• Study coordinator: Guillaume BAUDRY, MD

Conditions Heart Failure