Heart failure breakthrough? trial tests stopping Beta-Blockers in recovered patients
NCT ID NCT06518694
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether people with heart failure whose heart function has returned to normal can safely stop taking beta-blockers. About 1,300 participants will either gradually stop their beta-blockers or continue them as usual. The goal is to see if stopping the drug leads to a relapse of heart failure or other heart problems, while potentially reducing side effects and medication burden.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- beta-blockers (discontinued with tapering)
- What this could lead to
- If successful, this could show that some heart failure patients with normalized heart function no longer need beta-blockers, simplifying their treatment and improving quality of life.
- What could go wrong
- This is a Phase 3 trial, but it's still uncertain whether stopping beta-blockers is safe. There is a risk of heart failure relapse, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2025
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years-old 2. Established diagnosis of HF for more than 12 months, from an ischemic or a non-ischemic origin 3. 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. 4. 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) 5. No or mild symptoms of HF (defined as NYHA functional class I or II) 6. No heart failure-related hospital admission within the last six months 7. 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 8. 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. 9. With or without ICD 10. Ability to provide written informed consent to participate to the study 11. Patient affiliated to Social Security Exclusion Criteria: 1. Atrial, supra-ventricular, or ventricular arrhythmias, in the last 12 months and/or requiring beta-blockers according to investigator. 2. Uncontrolled arterial hypertension according to investigator decision. 3. Symptomatic angina or evidence of infra-clinic myocardial ischemia requiring beta-blockers according to investigator decision. 4. Cardiac resynchronization therapy 5. 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. 6. History of severe outcomes at beta-blockers interruption: HF relapse, occurrence of arrythmias 7. Severe valvulopathy, restrictive, infiltrative or hypertrophic cardiomyopathy, constrictive pericarditis, or acute myocarditis within 3 months prior to inclusion Visit. 8. Planned coronary, carotid, or peripheral artery revascularization known at the day of inclusion 9. Chronic renal failure with eGFR \<20mL/Min per 1.73m² (CKD-Epi) at inclusion 10. Hepatic insufficiency classified as Child-Pugh B or C at the inclusion Visit. 11. Any past solid organ transplantation or planned organ transplantation within 12 months 12. Any condition other than HF that could limit survival to less than one year 13. Pregnancy or breastfeeding women or women of childbearing potential without adequate contraceptive method 14. Current participation in another interventional trial. 15. Patient under legal protection (protection of the court, or in curatorship or guardianship). 16. Any disorder, unwillingness or inability, which in investigator's opinion, might jeopardise the patient's safety or compliance with the protocol
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hôpital Européen Georges Pompidou
RECRUITINGParis, IDF, 75015, France
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