Beta-blOckers discoNtinuation in patients presenting heart FaIlure with REcovered left ventricular ejection fractio

Phase 1

• Conditions: Heart failure; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-508798-94-00
• Lead Sponsor: Assistance Publique Hopitaux De Paris

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1300

Inclusion Criteria

Age = 18 years-old, Ability to provide written informed consent to participate to the study, Patient affiliated to Social Security, 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 SGLT2i, of RAAS blocker (Angiotensin receptor neprilysin inhibitor OR Angiotensin-converting-enzyme-inhibitors OR Angiotensin II receptors blockers), and of MRA if tolerated). Loop diuretics use is adjusted to congestive signs according to physicians’ decision, With or without ICD

Exclusion Criteria

Atrial, supra-ventricular, or ventricular arrhythmias, in the last 12 months and/or requiring beta-blockers according to investigator, 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 jeopardize the patient’s safety or compliance with the protocol, 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified