Actively Recruiting
Beta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-16
1300
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 evidence-based medical and device therapies. Some of these patients (estimated from 20 to 30%) even display a complete normalization of LVEF (i.e., \>50%) and are now recognized as a specific sub-group of patients named Heart Failure with recovered Ejection Fraction (HFrecovEF). Different studies have shown that reverse remodeling with recovery of cardiac function and stabilization of HF symptoms are associated with improved clinical outcomes over the long-term. Whether these patients present a stable remission of HF and could benefit a therapeutic de-escalation is however unclear. Until novel data are provided, medical therapies are thus continued indefinitely in these stable patients with HFrecovEF. Current guidelines for the management of patients with heart failure and a reduced left ventricular ejection fraction recommends a comprehensive therapy, including 5 different therapeutic classes (RAAS blockers (with a preference for ARNi) + Beta-Blockers + SGLT2i + Mineraloreceptors Antagonists + or - Diuretics ). None of these therapies (with the recent exception of one SGLT2i, i.e. Dapagliflozin) have been tested in patients with HFrecovEF. In addition, it is unclear whether the benefit of older therapies (notably beta-blockers) remains in patients receiving modern comprehensive therapy as newer drugs were tested as add-on therapies. This polypharmacy is lowering adherence and is creating a challenge for physicians and patients. Betablockers are notably associated with frequent side effects, a limited tolerance and a significant reduction of quality of life. Their efficacy on outcomes is not established in patients with normal LVEF. Pilot studies have suggested that Beta-blockers interruption in patients with HF and normal EF was associated with functional improvement.
CONDITIONS
Official Title
Beta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with heart failure for more than 12 months
- History of reduced left ventricular ejection fraction (≤ 45%) followed by normalized LVEF (≥ 50%) for the last 6 months confirmed by echocardiography
- Normal left ventricular end diastolic volume indexed to body surface area (≤ 74 ml/m2 in men and ≤ 61 ml/m2 in women)
- No or mild heart failure symptoms (NYHA class I or II)
- No heart failure-related hospital admission within the last six months
- Currently receiving beta-blockers indicated for chronic heart failure for at least 12 months
- Receiving guideline-directed optimal medical therapy for at least 12 months, including SGLT2 inhibitors, RAAS blockers (ARNI, ACE-I, or ARBs), MRA if tolerated, and loop diuretics as needed
- No major adjustments in heart failure therapy within 3 months prior to inclusion
- With or without implantable cardioverter defibrillator (ICD)
- Able to provide written informed consent
- Affiliated to Social Security
You will not qualify if you...
- Atrial, supraventricular, or ventricular arrhythmias in the last 12 months or requiring beta-blockers
- Uncontrolled high blood pressure as per investigator decision
- Symptomatic angina or myocardial ischemia requiring beta-blockers
- Receiving cardiac resynchronization therapy
- Extra-cardiac conditions requiring beta-blockers (e.g., migraine, essential tremor, liver cirrhosis with bleeding risk, hyperthyroidism)
- History of severe adverse events after stopping beta-blockers such as heart failure relapse or arrhythmias
- Severe valve disease, restrictive, infiltrative, or hypertrophic cardiomyopathy, constrictive pericarditis, or recent acute myocarditis
- Planned coronary, carotid, or peripheral artery revascularization
- Chronic kidney failure with eGFR below 20 mL/min/1.73m²
- Liver failure classified as Child-Pugh B or C
- Past or planned solid organ transplantation within 12 months
- Any condition limiting survival to less than one year other than heart failure
- Pregnancy, breastfeeding, or women of childbearing potential without adequate contraception
- Participation in another interventional trial
- Under legal protection (court guardianship or similar)
- Any condition or inability that may affect safety or protocol compliance as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hôpital Européen Georges Pompidou
Paris, IDF, France, 75015
Actively Recruiting
Research Team
J
Jean Sébastien HULOT, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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