Status:
NOT_YET_RECRUITING
Beta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A significant proportion of patients initially diagnosed with heart failure and a reduced left ventricular ejection fraction (LVEF\<40%, HFrEF) presents a substantial improvement in response to eviden...
Detailed Description
BONFIRE is a National, Multicenter, Randomised, Open-label, Non-inferiority, Blinded endpoints prospective trial. The study concerns HF patients with a history of reduced left ventricular ejection fr...
Eligibility Criteria
Inclusion
- Age ≥ 18 years-old
- Established diagnosis of HF for more than 12 months, from an ischemic or a non-ischemic origin
- With a documented history of reduced left ventricular ejection fraction (LVEF ≤ 45%), followed by a normalisation of LVEF (≥ 50 % for the last 6 months) assessed by cardiac echography.
- With a left ventricular end diastolic volume indexed to body surface area (LVEDVi) within the normal range (≤74ml/m2 in men and ≤61 ml/m2 in women)
- No or mild symptoms of HF (defined as NYHA functional class I or II)
- No heart failure-related hospital admission within the last six months
- Currently receiving a beta-blocker indicated for chronic heart failure (i.e. bisoprolol or carvedilol or metoprolol or nebivolol) whatever the dose used, for at least 12 months
- And receiving the guideline-directed optimal medical therapy for at least 12 months (i.e., maximal tolerated dose of SGLT2 inhibitors, and of RAAS blocker (Angiotensin receptor neprilysin inhibitor OR Angiotensin-converting-enzyme-inhibitors OR Angiotensin II receptors blockers), and MRA if tolerated). Loop diuretics use is adjusted to congestive signs according to physicians' decision.
- With or without ICD
- Ability to provide written informed consent to participate to the study
- Patient affiliated to Social Security
Exclusion
- Atrial, supra-ventricular, or ventricular arrhythmias, in the last 12 months and/or requiring beta-blockers according to investigator.
- Uncontrolled arterial hypertension according to investigator decision.
- Symptomatic angina or evidence of infra-clinic myocardial ischemia requiring beta-blockers according to investigator decision.
- Cardiac resynchronization therapy
- Extra-cardiac conditions requiring beta-blockers (migraine, essential tremor, prevention of bleeding from esophageal varices in patients with liver cirrhosis, adrenergic symptoms of hyperthyroidism…) according to investigator decision.
- History of severe outcomes at beta-blockers interruption: HF relapse, occurrence of arrythmias
- Severe valvulopathy, restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, or acute myocarditis within 3 months prior to inclusion Visit.
- Planned coronary, carotid, or peripheral artery revascularization known at the day of inclusion
- Chronic renal failure with eGFR \<20mL/Min per 1.73m² (CKD-Epi) at inclusion
- Hepatic insufficiency classified as Child-Pugh B or C at the inclusion Visit.
- Any past solid organ transplantation or planned organ transplantation within 12 months
- Any condition other than HF that could limit survival to less than one year
- Pregnancy or breastfeeding women or women of childbearing potential without adequate contraceptive method
- Current participation in another interventional trial.
- Patient under legal protection (protection of the court, or in curatorship or guardianship).
- Any disorder, unwillingness or inability, which in investigator's opinion, might jeopardise the patient's safety or compliance with the protocol
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
1300 Patients enrolled
Trial Details
Trial ID
NCT06518694
Start Date
October 1 2024
End Date
October 1 2027
Last Update
July 24 2024
Active Locations (1)
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1
Hôpital Européen Georges Pompidou
Paris, IDF, France, 75015