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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

11 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

Beta-Blockers – These medications are typically administered orally in tablet form. They are well-established in medical practice and literature, primarily used to manage heart conditions. The main therapeutic indication for beta-blockers is heart failure, particularly in patients with a recovered left ventricular ejection fraction. At the molecular level, beta-blockers work by blocking the effects of adrenaline on the heart, which helps to slow the heart rate and reduce blood pressure. They belong to the pharmacological class of beta-adrenergic blocking agents.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508798-94-00Protocol codeAPHP230833Estimated enrolment1 300 patientsSponsorAssistance Publique Hopitaux De Paris

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