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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

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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
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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (38)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Centre Hospitalier Universitaire D'AngersAngersFranceRecruiting
Centre Hospitalier d'AuxerreAuxerreFranceRecruiting
Centre Hospitalier d'AvignonAvignonFranceRecruiting
Hospices Civils de LyonBronFranceRecruiting
Centre Hospitalier Universitaire De Caen NormandieCaen Cedex 9FranceRecruiting
Centre Hospitalier de CholetCholetFranceRecruiting
Chu Gabriel MontpiedClermont-FerrandFranceRecruiting
Centre Hospitalier Universitaire de DijonDijonFranceRecruiting
CHU De MartiniqueFort De France CedexFranceRecruiting
Union Mut Gestion Groupe Hosp Mutualiste De GrenobleGrenobleFranceRecruiting
Centre Hospitalier Universitaire Grenoble AlpesGrenoble Cedex 9FranceRecruiting
Hospitalite Saint Thomas De VilleneuveLamballe-ArmorFranceRecruiting
Centre Hospitalier De LavalLavalFranceRecruiting
Centre Hospitalier De VersaillesLe Chesnay RocquencourtFranceRecruiting
Les Hopitaux De ChartresLe CoudrayFranceRecruiting
Assistance Publique Hopitaux De ParisLe Kremlin-BicetreFranceRecruiting
HPM NordLilleFranceRecruiting
Centre Hospitalier Et Universitaire de LimogesLimogesFranceRecruiting
Centre Hospitalier Regional De MarseilleMarseilleFranceRecruiting
Groupe Hospitalier Du Sud Ile De FranceMelunFranceRecruiting
Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5FranceRecruiting
CHRU de NancyNancyFranceRecruiting
Centre Hospitalier Universitaire de NantesNantesFranceRecruiting
Centre Hospitalier Universitaire De NimesNimes Cedex 9FranceRecruiting
Assistance Publique Hopitaux de ParisParisFranceRecruiting
Assistance Publique Hopitaux De ParisParis Cedex 10FranceRecruiting
GIE Groupe hospitalier Paris Saint-Joseph/VinciParis Cedex 14FranceRecruiting
Assistance Publique Hopitaux De ParisParis Cedex 18FranceRecruiting
Centre Hospitalier Universitaire de BordeauxPessacFranceRecruiting
Hospices Civils de LyonPierre-BéniteFranceRecruiting
Centre Hospitalier Universitaire de PoitiersPoitiersFranceRecruiting
Hôpital NOVOPontoiseFranceRecruiting
Centre Hospitalier Universitaire de RennesRennesFranceRecruiting
CHU De RouenRouen CedexFranceRecruiting
Societe D'Exploitation Du Centre Cardiologique Du NordSaint-DenisFranceRecruiting
Les Hopitaux Universitaires De StrasbourgStrasbourg CedexFranceRecruiting
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-MerToulonFranceRecruiting
Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9FranceRecruiting

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