Tests stopping beta-blocker medicine in adults with heart failure and recovered heart pumping
Tests stopping beta-blockers compared with continuing them in adults with heart failure.
Key facts
- Who runs it
- Assistance Publique Hopitaux De Paris
- Where
- Angers, Auxerre, Avignon, Bron, Caen Cedex 9, Cholet, Clermont-Ferrand, Dijon, Fort De France Cedex, Grenoble, Grenoble Cedex 9, Lamballe-Armor, Laval, Le Chesnay Rocquencourt, Le Coudray, Le Kremlin-Bicetre, Lille, Limoges, Marseille, Melun, Montpellier Cedex 5, Nancy, Nantes, Nimes Cedex 9, Paris, Paris Cedex 10, Paris Cedex 14, Paris Cedex 18, Pessac, Pierre-Bénite, Poitiers, Pontoise, Rennes, Rouen Cedex, Saint-Denis, Strasbourg Cedex, Toulon, and Toulouse Cedex 9, FranceSee the 38 sites
- Trial code
- Registry title
- Beta-blOckers discoNtinuation in patients presenting heart FaIlure with REcovered left ventricular ejection fraction
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 1,300 people, planned
- Started
- 11 Feb 2025
- Expected to end
- 30 Jun 2028
- Type of study
- Interventional
- Record updated
- 28 August 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with heart failure whose heart pumping has returned to normal and who take a beta-blocker. It tests stopping the beta-blocker versus continuing it.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Heart failure for more than 12 months, from an ischemic or non-ischemic cause. Past reduced LVEF (≤ 45%), now normal (≥ 50% for the last 6 months). Normal LVEDVi. No or mild symptoms (NYHA class I or II). No heart failure hospital stay in the last six months.
- Earlier treatment
- Taking a beta-blocker for heart failure (bisoprolol, carvedilol, metoprolol or nebivolol) for at least 12 months, at any dose. Also on optimal heart failure medicines (SGLT2i, RAAS blocker, and MRA if tolerated) for at least 12 months, with no major change in the last 3 months.
- Biomarker or test result
- Heart ultrasound with LVEF ≥ 50% for the last 6 months. LVEDVi ≤74ml/m2 in men and ≤61 ml/m2 in women.
Main reasons for not taking part
- Atrial, supra-ventricular or ventricular rhythm problems in the last 12 months, or needing beta-blockers
- Cardiac resynchronization therapy
- Other conditions that need beta-blockers, such as angina, migraine or uncontrolled high blood pressure
- Past solid organ transplant, or one planned within 12 months
- Pregnancy or breastfeeding, or childbearing potential without adequate contraception
The registry criteria, word for word
Show all 27 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- 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
- Chronic renal failure with eGFR <20mL/Min per 1.73m² (CKD-Epi) at 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)
- Planned coronary, carotid, or peripheral artery revascularization known at the day of inclusion
Where in France
- Centre Hospitalier Universitaire D'AngersAngers, FranceTaking people
- Centre Hospitalier d'AuxerreAuxerre, FranceTaking people
- Centre Hospitalier d'AvignonAvignon, FranceTaking people
- Hospices Civils de LyonBron, FranceTaking people
- Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9, FranceTaking people
- Centre Hospitalier de CholetCholet, FranceTaking people
- Chu Gabriel MontpiedClermont-Ferrand, FranceTaking people
- Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
- CHU De MartiniqueFort De France Cedex, FranceTaking people
- Union Mut Gestion Groupe Hosp Mutualiste De GrenobleGrenoble, FranceTaking people
- Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9, FranceTaking people
- Hospitalite Saint Thomas De VilleneuveLamballe-Armor, FranceTaking people
- Centre Hospitalier De LavalLaval, FranceTaking people
- Centre Hospitalier De VersaillesLe Chesnay Rocquencourt, FranceTaking people
- Les Hopitaux De ChartresLe Coudray, FranceTaking people
- Assistance Publique Hopitaux De ParisLe Kremlin-Bicetre, FranceTaking people
- HPM NordLille, FranceTaking people
- Centre Hospitalier Et Universitaire de LimogesLimoges, FranceTaking people
- Centre Hospitalier Regional De MarseilleMarseille, FranceTaking people
- Groupe Hospitalier Du Sud Ile De FranceMelun, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- CHRU de NancyNancy, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- Centre Hospitalier Universitaire De NimesNimes Cedex 9, FranceTaking people
- Assistance Publique Hopitaux de ParisParis, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 10, FranceTaking people
- GIE Groupe hospitalier Paris Saint-Joseph/VinciParis Cedex 14, FranceTaking people
- Assistance Publique Hopitaux De ParisParis Cedex 18, FranceTaking people
- Centre Hospitalier Universitaire de BordeauxPessac, FranceTaking people
- Hospices Civils de LyonPierre-Bénite, FranceTaking people
- Centre Hospitalier Universitaire de PoitiersPoitiers, FranceTaking people
- Hôpital NOVOPontoise, FranceTaking people
- Centre Hospitalier Universitaire de RennesRennes, FranceTaking people
- CHU De RouenRouen Cedex, FranceTaking people
- Societe D'Exploitation Du Centre Cardiologique Du NordSaint-Denis, FranceTaking people
- Les Hopitaux Universitaires De StrasbourgStrasbourg Cedex, FranceTaking people
- Centre Hospitalier Intercommunal Toulon / La Seine-Sur-MerToulon, FranceTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
About the trial
What the trial wants to find out
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- BONFIRE - Beta-blockers discontinuation in patients presenting heart failure with recovered left ventricular ejection fraction
- Plain-language title
- Tests stopping beta-blocker medicine in adults with heart failure and recovered heart pumpingGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 28 August 2026