2023-508798-94-00RecruitingPhase 3
Beta-blOckers discoNtinuation in patients presenting heart FaIlure with REcovered left ventricular ejection fraction
BONFIRE - Beta-blockers discontinuation in patients presenting heart failure with recovered left ventricular ejection fraction
Source: EU CTIS (euclinicaltrials.eu) · Last updated 28 Aug 2026
Brief summary (registry, in English)
To demonstrate the non-inferiority of Βeta-Blockers therapy discontinuation in patients with HF and recovered LVEF (stratified on ischemic vs non-ischemic origin) in terms of HF relapse and adverse cardiovascular outcomes as compared to the continuation of Beta-Blockers.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1300 (estimated)
- First submitted
- 4 Mar 2024
- Start date
- 11 Feb 2025
- Lead sponsor
- Assistance Publique Hopitaux De Paris
- Diseases
- Heart failure
- EU CT number
- 2023-508798-94-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1300
- 38 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any past solid organ transplantation or planned organ transplantation within 12 months
- Severe valvulopathy, restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, or acute myocarditis within 3 months prior to inclusion visit
Other illness
- 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 condition other than HF that could limit survival to less than one year
- 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
Lab values
- Chronic renal failure with eGFR <20mL/Min per 1.73m² (CKD-Epi) at inclusion
Other
- 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).
- Planned coronary, carotid, or peripheral artery revascularization known at the day of inclusion
Who the study is looking for
- 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. No initiation or major adjustment in heart failure therapies should have occurred during the 3 months prior to study inclusion.
- With or without ICD
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire D'Angers | Angers | France | Recruiting |
| Centre Hospitalier d'Auxerre | Auxerre | France | Recruiting |
| Centre Hospitalier d'Avignon | Avignon | France | Recruiting |
| Hospices Civils de Lyon | Bron | France | Recruiting |
| Centre Hospitalier Universitaire De Caen Normandie | Caen Cedex 9 | France | Recruiting |
| Centre Hospitalier de Cholet | Cholet | France | Recruiting |
| Chu Gabriel Montpied | Clermont-Ferrand | France | Recruiting |
| Centre Hospitalier Universitaire de Dijon | Dijon | France | Recruiting |
| CHU De Martinique | Fort De France Cedex | France | Recruiting |
| Union Mut Gestion Groupe Hosp Mutualiste De Grenoble | Grenoble | France | Recruiting |
| Centre Hospitalier Universitaire Grenoble Alpes | Grenoble Cedex 9 | France | Recruiting |
| Hospitalite Saint Thomas De Villeneuve | Lamballe-Armor | France | Recruiting |
| Centre Hospitalier De Laval | Laval | France | Recruiting |
| Centre Hospitalier De Versailles | Le Chesnay Rocquencourt | France | Recruiting |
| Les Hopitaux De Chartres | Le Coudray | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Le Kremlin-Bicetre | France | Recruiting |
| HPM Nord | Lille | France | Recruiting |
| Centre Hospitalier Et Universitaire de Limoges | Limoges | France | Recruiting |
| Centre Hospitalier Regional De Marseille | Marseille | France | Recruiting |
| Groupe Hospitalier Du Sud Ile De France | Melun | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier | Montpellier Cedex 5 | France | Recruiting |
| CHRU de Nancy | Nancy | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Recruiting |
| Centre Hospitalier Universitaire De Nimes | Nimes Cedex 9 | France | Recruiting |
| Assistance Publique Hopitaux de Paris | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 10 | France | Recruiting |
| GIE Groupe hospitalier Paris Saint-Joseph/Vinci | Paris Cedex 14 | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 18 | France | Recruiting |
| Centre Hospitalier Universitaire de Bordeaux | Pessac | France | Recruiting |
| Hospices Civils de Lyon | Pierre-Bénite | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | France | Recruiting |
| Hôpital NOVO | Pontoise | France | Recruiting |
| Centre Hospitalier Universitaire de Rennes | Rennes | France | Recruiting |
| CHU De Rouen | Rouen Cedex | France | Recruiting |
| Societe D'Exploitation Du Centre Cardiologique Du Nord | Saint-Denis | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg | Strasbourg Cedex | France | Recruiting |
| Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer | Toulon | France | Recruiting |
| Centre Hospitalier Universitaire De Toulouse | Toulouse Cedex 9 | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.