RecruitingPhase 3NCT06518694

Beta-blOckers discoNtinuation in Patients Presenting Heart FaIlure With REcovered Left Ventricular Ejection Fraction


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

1,300 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A significant proportion of patients initially diagnosed with heart failure and a reduced left ventricular ejection fraction (LVEF\<40%, HFrEF) presents a substantial improvement in response to evidence-based medical and device therapies. Some of these patients (estimated from 20 to 30%) even display a complete normalization of LVEF (i.e., \>50%) and are now recognized as a specific sub-group of patients named Heart Failure with recovered Ejection Fraction (HFrecovEF). Different studies have shown that reverse remodeling with recovery of cardiac function and stabilization of HF symptoms are associated with improved clinical outcomes over the long-term. Whether these patients present a stable remission of HF and could benefit a therapeutic de-escalation is however unclear. Until novel data are provided, medical therapies are thus continued indefinitely in these stable patients with HFrecovEF. Current guidelines for the management of patients with heart failure and a reduced left ventricular ejection fraction recommends a comprehensive therapy, including 5 different therapeutic classes (RAAS blockers (with a preference for ARNi) + Beta-Blockers + SGLT2i + Mineraloreceptors Antagonists + or - Diuretics ). None of these therapies (with the recent exception of one SGLT2i, i.e. Dapagliflozin) have been tested in patients with HFrecovEF. In addition, it is unclear whether the benefit of older therapies (notably beta-blockers) remains in patients receiving modern comprehensive therapy as newer drugs were tested as add-on therapies. This polypharmacy is lowering adherence and is creating a challenge for physicians and patients. Betablockers are notably associated with frequent side effects, a limited tolerance and a significant reduction of quality of life. Their efficacy on outcomes is not established in patients with normal LVEF. Pilot studies have suggested that Beta-blockers interruption in patients with HF and normal EF was associated with functional improvement.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether it is safe to stop taking beta-blocker heart medications in people whose heart function has fully recovered after previously having heart failure with reduced pumping strength. Heart failure guidelines recommend lifelong beta-blockers, but this trial tests whether stopping them is safe in people whose hearts have normalized. **You may be eligible if...** - You are 18 or older - You were diagnosed with heart failure more than 12 months ago (from any cause) - Your heart's pumping function (ejection fraction) was previously 45% or less, but has now normalized to 50% or higher for at least the last 6 months - Your heart size is within the normal range on echocardiogram - Your heart failure symptoms are minimal (NYHA class I or II) - You have not been hospitalized for heart failure in the past 6 months - You are currently on a stable dose of a beta-blocker **You may NOT be eligible if...** - Your ejection fraction has not fully recovered - You have an ongoing condition that requires beta-blockers (such as angina or certain arrhythmias) - You have had a recent hospitalization for heart failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGΒeta-Blockers discontinued (with tapering)

The experimental group will undergo discontinuation of their beta-blockers treatment during the study period. The tapering of beta-blocker will start on the day after randomisation and is based on a reduction by half-dose every 48 hours (1/2 maximally recommended dose for 48 hours, then ¼ maximally recommended dose for 48 hours) until reaching the minimal recommended dosage (1/8 maximally recommended dose) for 48 hours before complete interruption of treatment. Consequently, the tapering will not be needed in patients already receiving the minimal recommended dosage (i.e., 1/8 dose) at inclusion, and these patients will be instructed to stop taking beta-blockers the day after randomisation.


Locations(1)

Hôpital Européen Georges Pompidou

Paris, IDF, France

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NCT06518694


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