Study on Stopping Beta-Blockers in Heart Failure Patients with Recovered Heart Function Using Carvedilol and Drug Combination

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What is this study about?

This clinical trial is focused on studying the effects of stopping the use of beta-blockers in patients who have experienced heart failure but have since shown improvement in their heart function. Heart failure is a condition where the heart does not pump blood as well as it should. Beta-blockers are medications that help manage heart conditions by slowing down the heart rate and reducing blood pressure. The study aims to see if patients who have recovered heart function can safely discontinue beta-blockers without experiencing a relapse of heart failure or other heart-related issues.

Participants in the study will be those who have been diagnosed with heart failure for over a year and have shown improvement in their heart’s ability to pump blood. The study will compare two groups: one group will stop taking beta-blockers, while the other will continue their medication. The trial will monitor the participants over a period ranging from one to four years to observe any changes in their heart condition, including any return of heart failure symptoms or other cardiovascular events.

In addition to beta-blockers, the study will also consider the effects of other medications commonly used in heart failure treatment, such as ACE inhibitors, Angiotensin II receptor blockers (ARBs), and SGLT2 inhibitors. These medications help manage heart failure by different mechanisms, such as relaxing blood vessels or helping the body remove excess glucose. The trial will assess the overall health and quality of life of participants, including any side effects from stopping beta-blockers, to determine the best approach for managing heart failure in patients with improved heart function.

1 enrollment

Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current treatment for heart failure.

Written informed consent is required to participate in the study.

2 initial assessment

An initial assessment is conducted to document the current health status, including heart function and any symptoms of heart failure.

This assessment includes a cardiac echography to confirm the normalization of the left ventricular ejection fraction (LVEF).

3 medication adjustment

Participants currently receiving beta-blockers for heart failure, such as bisoprolol, carvedilol, metoprolol, or nebivolol, will have their treatment plan reviewed.

The study aims to evaluate the effects of discontinuing beta-blockers in patients with recovered heart function.

4 follow-up visits

Regular follow-up visits are scheduled to monitor heart function and overall health.

These visits include assessments of LVEF, heart failure symptoms, and other health indicators.

5 medication monitoring

Participants continue to receive other heart failure medications as per standard guidelines, including SGLT2 inhibitors, RAAS blockers, and loop diuretics as needed.

The dosage and necessity of these medications are adjusted based on individual health needs.

6 evaluation of outcomes

The primary outcome is the occurrence of heart failure relapse or adverse cardiovascular events.

Secondary outcomes include changes in heart function, hospitalization rates, and quality of life assessments.

7 study completion

The study is expected to last between one to four years, depending on individual participation and health outcomes.

Final assessments are conducted to evaluate the long-term effects of beta-blocker discontinuation.

Who Can Join the Study?

Must be 18 years or older.
Must be able to provide written consent to join the study.
Must be affiliated with Social Security.
Must have a diagnosed heart failure for more than 12 months, which can be from an ischemic (related to reduced blood flow) or non-ischemic (not related to blood flow) origin.
Must have a history of reduced left ventricular ejection fraction (LVEF), which is a measure of how well the heart pumps blood, that was 45% or less, followed by a normalization of LVEF to 50% or more for the last 6 months, as checked by a heart ultrasound.
Must have a left ventricular end diastolic volume indexed to body surface area (LVEDVi) within the normal range, which is 74 ml/m² or less for men and 61 ml/m² or less for women. This is a measure of the size of the heart’s left ventricle.
Must have no or mild symptoms of heart failure, defined as NYHA functional class I or II. This is a classification of how heart failure affects daily activities.
Must not have been hospitalized for heart failure in the last six months.
Must be currently taking a beta-blocker for chronic heart failure, such as bisoprolol, carvedilol, metoprolol, or nebivolol, for at least 12 months, regardless of the dose.
Must be receiving the optimal medical therapy for at least 12 months, which includes the highest tolerated dose of SGLT2 inhibitors, RAAS blockers (like Angiotensin receptor neprilysin inhibitor, Angiotensin-converting-enzyme inhibitors, or Angiotensin II receptor blockers), and MRA if tolerated. The use of loop diuretics is adjusted based on signs of fluid retention as decided by doctors.
Can have an ICD (implantable cardioverter-defibrillator) or not.

Who Cannot Join the Study?

Patients who currently have heart failure cannot participate. Heart failure is a condition where the heart doesn’t pump blood as well as it should.
Patients who have not recovered their left ventricular ejection fraction (LVEF) are excluded. LVEF is a measurement of how much blood the left ventricle of the heart pumps out with each contraction.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who belong to a vulnerable population are not eligible. Vulnerable populations include groups that may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oncopole Claudius Regaud	Toulouse	France
CHU Grenoble Alpes	La Tronche	France
Centre Hospitalier De Laval	Laval	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Groupe Hospitalier Du Sud Ile De France	Melun	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital Beaujon	Clichy	France
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Coirzr Hcqxmngfldo Uufaclbranukn Dm Cyne Nilurlelu	Caen	France
Aafgrpxggd Pzhnguyd Hwrdyido De Mvdknlffa	Marseille	France
Cvmyhg Hlemmsltvmi Uwgoutedebkgr Dy Mhxcxxhrnxq	Montpellier	France
Cynm Ds Nvloo	Vandoeuvre Les Nancy	France
Cahgzj Htqyegjyakt Uoodcciziegxz Dq Rkqism	Rennes	France
Cgqbtv Hxbyaxhkrje Uaciairpouqtz Dz Nsakk	Nimes	France
Cnhhko Hxqqlzbvmxs Lrhq Srt	Pierre Benite	France
Cylkdi Hyhocumidhf Rqifxbtl Dgqzuqpxfbpknf	Angers	France
Htvabhnt Utkzfywpponoot Szaejjxtpz &vibhqh Hrizops dc Hamcwsafajw	STRASBOURG, Alsace	France
Cvgvol Hmuutbuhfih Ienefjixdveyv Tqpsxr / Lq Sghqhfhlzexkq	Toulon	France
Hxv Ncjq	Lille	France
Cdk Dr Mabmzmqdyh	Fort De France	France
Scmufsf Dnknyuorbqawwrczavrd Dm Cgunhg Cneyqmqknfiia Dg Nteo	St Denis	France
Cqeaew Hsfclpurstl Uwdlptbjtbmic drptewlus	Orléans	France
Cwjjur Hgewswnmudv Ej Uargexsgtfsri Dr Lhzbxyu	Limoges	France
Cqinqr Hyocqmqmksd Ubrlmuueymesr Db Douai	Dijon	France
Hjansmo Nnxr	Pontoise	France
Csjvhe Hlbswsmignw Dz Csyqdp	Cholet	France
Gklkhh Hrxrbmkywix Upljmwhuijguj Plbnh Pywyeazpnkh El Nmqgneyknpqm	Paris	France
Csljqg Hywsbxyjwfd Ujirvwkaonmup Da Pvyqknpk	Poitiers	France
Csi Gslchzflvqljnxch	Clermont Ferrand	France
Uddmd Mcd Gmlgdkv Gvuhcv Huzy Mrpvqjwlnu Dw Gdxpmzrh	Grenoble	France
Lpb Hbcmxtsj Ds Cscmpikb	Le Coudray	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.06.2024

Trial locations

Investigated Drugs:

Beta-Blockers are medications used to manage heart conditions by slowing down the heart rate and reducing blood pressure. In this trial, the focus is on whether stopping these medications in patients who have recovered heart function is as safe as continuing them. The study aims to see if stopping the medication leads to any relapse of heart failure or other heart-related issues compared to those who keep taking it.

Investigated Diseases:

Cardiac failure

Heart Failure – Heart failure is a condition where the heart is unable to pump blood effectively, leading to insufficient blood flow to meet the body’s needs. It can result from various causes, including damage from a heart attack or high blood pressure. As the condition progresses, individuals may experience symptoms such as fatigue, shortness of breath, and swelling in the legs and ankles. Over time, the heart may become enlarged, and its pumping ability may further decline. This can lead to fluid buildup in the lungs and other parts of the body, worsening the symptoms. Heart failure can be classified based on the side of the heart affected or the stage of the disease.

Trial ID:

2023-508798-94-00

Protocol code:

APHP230833

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Stopping Beta-Blockers in Heart Failure Patients with Recovered Heart Function Using Carvedilol and Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?