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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 Status
Groupe Hospitalier Du Sud Ile De France Melun France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Oncopole Claudius Regaud Toulouse France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier De Versailles Le Chesnay-Rocquencourt France
Centre Hospitalier Universitaire Rouen Rouen France
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
CHU Gabriel-Montpied Clermont Ferrand France
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble Grenoble France
Les Hopitaux De Chartres Le Coudray France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer Toulon France
Centre Hospitalier Universitaire d’Orléans Orléans France
Centre Hospitalier Universitaire De Montpellier Montpellier France
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital NOVO Pontoise France
Centre Hospitalier De Cholet Cholet France
Centre Hospitalier Universitaire De Rennes Rennes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Centre Hospitalier Universitaire De Caen Normandie Caen France
CHU De Martinique Fort De France France
Hbq Nrcd Lille France
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Cohjgy Hzwgsgjpagu Rddswevi Dcfdutvokrtrhz Angers France
Hiaslgvl Uwrzsphuitdqyt Sbfxsqdklc &fljqcj Huyzbxj dc Hijmmkwazbp STRASBOURG, Alsace France
Spndkun Dcyvdoztkrunlbdrgwrz Dr Csjcfr Cuiashebltlan Dg Ntek St Denis France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France 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.

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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