Recruiting

BONFIREBeta-Blockers Discontinuation in Heart Failure Patients with Recovered Ejection Fraction

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Study Aim

This study aims to evaluate the effects of discontinuing beta-blockers in heart failure patients who have recovered their heart's pumping ability, focusing on the risk of death, heart-related hospitalizations, and heart failure relapse.

What is being tested

Βeta-Blockers discontinued (with tapering)

Drug
Who is being recruted

Cardiovascular Diseases+3

+ Death

+ Heart Diseases

Over 18 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 3
Interventional
Study Start: February 2025
See protocol details

Summary

Principal SponsorAssistance Publique - Hôpitaux de Paris
Study ContactJean Sébastien HULOT, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 11, 2025

Actual date on which the first participant was enrolled.

This study focuses on patients who have had heart failure but have shown improvement in heart function. Specifically, it involves those whose heart's pumping ability has improved to a normal range, as measured by an echocardiogram. The aim is to determine if patients can safely stop taking beta-blockers, a type of heart medication, while continuing their other heart failure treatments. The study is important because it could help reduce medication burden and potential side effects if beta-blockers are no longer needed for certain patients. Participants in the study will be divided into two groups. One group will gradually stop taking beta-blockers, while the other group will continue their current heart failure treatment, including beta-blockers. The study will compare the outcomes of both groups to see if stopping beta-blockers is safe and doesn't lead to worse heart function or more symptoms. Participants' heart health will be closely monitored to measure the safety and effectiveness of discontinuing beta-blocker therapy. This approach helps ensure any changes in heart health are detected and managed promptly.

Official TitleBeta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction
NCT06518694
Principal SponsorAssistance Publique - Hôpitaux de Paris
Study ContactJean Sébastien HULOT, MD, PhD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDeathHeart DiseasesHeart FailurePathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

11 inclusion criteria required to participate
Age ≥ 18 years-old
Established diagnosis of HF for more than 12 months, from an ischemic or a non-ischemic origin
No or mild symptoms of HF (defined as NYHA functional class I or II)
With or without ICD
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15 exclusion criteria prevent from participating
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
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
In this group, participants will gradually stop taking their Beta-Blockers while continuing with other recommended medications for heart failure.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hôpital Européen Georges Pompidou

Paris, FranceOpen Hôpital Européen Georges Pompidou in Google Maps
Recruiting
One Study Center