Actively Recruiting
Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
Led by Central Hospital, Nancy, France · Updated on 2025-09-11
103
Participants Needed
11
Research Sites
106 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Heart failure affects 1 to 2% of the adult population in developed countries, representing about 55 million people worldwide. Advanced heart failure is a condition where the heart can no longer provide sufficient cardiac output or equilibrate pressures within its chambers, leading to symptoms such as shortness of breath, fatigue, and water and salt retention. Heart failure affects the kidneys by reducing blood flow directed to them, sometimes leading to kidney congestion. In the long term, this can degrade kidney function. Common medications used to treat heart failure, such as diuretics, can sometimes worsen kidney failure. This link between the heart and the kidneys is known as cardio-renal syndrome and requires careful management of both organs to prevent mutual degradation. Dapagliflozin is an SGLT2 inhibitor medication used to treat type 2 diabetes, heart failure, and certain kidney diseases. It helps reduce blood sugar, improve heart and kidney function, while promoting the elimination of excess salt and water. However, there are limited data regarding the progression of cardio-renal interactions in patients with advanced heart failure. Yet, advanced heart failure is often associated with kidney dysfunction. The protein called suPAR is found in the blood of patients developing kidney disease and/or during the onset of acute kidney injury. This protein will allow to characterize a population of patients with advanced heart failure receiving optimized medical treatment, including dapagliflozin. The main objective of this research is to assess, based on the suPAR protein level in the blood, the progression of cardio-renal damage between inclusion and 6 months in patients with advanced heart failure who are listed for a heart transplant and treated with a therapy including dapagliflozin. The study plans 5 visits over 12 months. The research will take place in the cardiology department of several French hospitals.
CONDITIONS
Official Title
Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years and older and up to 85 years
- New York Heart Association (NYHA) class 3 or higher
- Left ventricular ejection fraction (LVEF) of 35% or less
- Receiving guideline-directed medical therapy including dapagliflozin at the maximal tolerated dose
- On the waiting list or in the registration process for heart transplantation with anticipated access to transplant in 6 months or in a pre-transplant pathway
- Affiliated with a social security scheme or beneficiary of one
- Provided informed consent after receiving full information about the clinical research
You will not qualify if you...
- Priority status on the heart transplant waiting list
- Heart failure caused by or linked with untreated thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis, or restrictive cardiomyopathy
- Dependence on inotropes or current mechanical circulatory support
- Acute decompensated heart failure or hospitalization for it within 30 days before enrollment
- History of any organ transplant or ventricular assistance device implantation, or expected implantation after enrollment
- Recent interventional procedures likely to improve heart failure symptoms within 60 days
- Glomerular filtration rate below 25 ml/min/1.73 m2
- Unstable or rapidly progressing kidney disease including specific kidney disorders
- Type 1 diabetes mellitus
- Participation in another interventional clinical trial
- Any condition other than heart failure limiting survival to less than 12 months
- Pregnancy or breastfeeding
- Being a vulnerable person under guardianship, curatorship, or legal protection
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Trial Site Locations
Total: 11 locations
1
Hospice Civil de Lyon - Hôpital Louis PRADEL
Bron, France, 69500
Not Yet Recruiting
2
CHU Grenoble
La Tronche, France, 38700
Not Yet Recruiting
3
CHU Montpellier
Montpellier, France, 34295
Not Yet Recruiting
4
Chu Nantes
Nantes, France, 44093
Not Yet Recruiting
5
Aphp Hegp
Paris, France, 75015
Not Yet Recruiting
6
CHU Bordeaux
Pessac, France, 33600
Not Yet Recruiting
7
CHU Rennes
Rennes, France, 35033
Not Yet Recruiting
8
Chu Rouen
Rouen, France, 76031
Not Yet Recruiting
9
CHU Strasbourg
Strasbourg, France, 67091
Not Yet Recruiting
10
CHU de Toulouse
Toulouse, France, 31059
Not Yet Recruiting
11
Chru Nancy
Vandœuvre-lès-Nancy, France, 54500
Actively Recruiting
Research Team
G
Guillaume BAUDRY, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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