Status:
WITHDRAWN
Acute Reno-Cardiac Action of Dapagliflozin In Advanced Heart Failure Patients on Heart Transplant Waiting List
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
End-stage Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In the DAPA-HF trial, the use of dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduced significantly the risk of worsening heart failure or death from cardiovascular causes co...
Eligibility Criteria
Inclusion
- Patient has signed informed consent form
- Age ≥ 18 years
- NYHA class ≥3
- LVEF ≤ 35%
- On optimal medical management (OMM) based on current heart failure practice guidelines at maximal tolerated dose for at least 30 days
- On waiting list for heart transplantation after multidisciplinary Heart Team decision, with anticipated access to heart transplant ≥ 6 months
Exclusion
- Priority patient on waiting list for heart transplantation
- Etiology of heart failure due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
- Inotrope dependent, existence of ongoing mechanical circulatory support
- Current acute decompensated HF or hospitalization due to decompensated HF \<30 days prior to the enrolment
- History of any organ transplant or prior implantation of a ventricular assistance device (VAD) or similar device, or implantation expected after randomization
- Presence of an active, uncontrolled infection
- Any recent interventional procedure likely to improve symptoms and heart failure status (coronary revascularization, percutaneous mitral valve intervention, cardiac resynchronization therapy) \< 60 days
- Glomerular filtration rate \< 30 ml/min/1.73 m2, according to CKD-EPI formula
- Unstable or rapidly progressing renal disease
- Patients with severe hepatic impairment (Child-Pugh class C)
- Chronic treatment with dapagliflozin or other SGLT2 inhibitors
- Patient with known history of severe drug intolerance to dapagliflozin or any excipients of the dapagliflozin (galactose, lactase)
- Type 1 diabetes mellitus
- Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or extraction of study drug at investigators' discretion
- Participation in another clinical interventional trial
- Any condition other than heart failure that could limit survival to less than 24 months
- Positive pregnancy test if of childbearing potential or refusal to use adequate contraception or women breast-feeding
- Patients with any legal protection measure
- Patients without any health coverage
- Psychiatric disease/disorder, irreversible cognitive dysfunction or psychological issues that are likely to impair compliance
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04782245
Start Date
September 1 2022
End Date
April 1 2024
Last Update
August 7 2023
Active Locations (1)
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1
Hôpital Pneumologique et Cardiovasculaire Louis Pradel
Bron, France, 69677