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NCT06518694RecruitingPhase 3

Beta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction

Source: ClinicalTrials.gov · Last updated 16 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1300 (estimated)
First submitted
21 Jun 2024
Start date
11 Feb 2025
Primary completion date
Oct 2027
Lead sponsor
Assistance Publique - Hôpitaux de Paris
NCT number
NCT06518694

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 1300
  • From 11 Feb 2025 to the primary completion date, Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe valvulopathy, restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, or acute myocarditis within 3 months prior to inclusion Visit.
  • Any past solid organ transplantation or planned organ transplantation within 12 months

Other illness

  • 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
  • Hepatic insufficiency classified as Child-Pugh B or C at the inclusion Visit.
  • Any condition other than HF that could limit survival to less than one year
  • Any disorder, unwillingness or inability, which in investigator's opinion, might jeopardise the patient's safety or compliance with the protocol

Lab values

  • Chronic renal failure with eGFR \<20mL/Min per 1.73m² (CKD-Epi) at inclusion

Other

  • Planned coronary, carotid, or peripheral artery revascularization known at the day of inclusion
  • 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).

Who the study is looking for

  • 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.
    • No initiation or major adjustment in heart failure therapies should have occurred during the 3 months prior to study inclusion.
  • With or without ICD
  • Ability to provide written informed consent to participate to the study
  • Patient affiliated to Social Security

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hôpital Européen Georges Pompidou
Coordinator of this site? Confirm its status
ParisFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.