Yükleniyor... / Loading...
This study examines the acute effects of Dapagliflozin on the kidneys and heart in patients with advanced heart failure who are on the heart transplant waiting list, by measuring suPAR levels in a blood sample. Adults aged 18-85 with NYHA class 3 or higher, a heart pumping strength (LVEF) of 35% or less, and on guideline-based therapy including dapagliflozin may take part. Conducted by Central Hospital, Nancy, France, this study without an assigned phase is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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)