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

RecruitingNAAges 18 Years - anyAllCentral Hospital, Nancy, France
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In plain words

What the trial is, and whether it could suit you

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 kid

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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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What it tests

  • Biological sample for the measurement of suPAR levels.
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Where

11 sites
Hospice Civil de Lyon - Hôpital Louis PRADEL
Bron, France
CHU Grenoble
La Tronche, France
CHU Montpellier
Montpellier, France
Chu Nantes
Nantes, France
Aphp Hegp
Paris, France
CHU Bordeaux
Pessac, France
CHU Rennes
Rennes, France
Chu Rouen
Rouen, France

…and 3 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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