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Study on Early Ablation and Use of Amiodarone, Beta-Blockers, or Sotalol for Atrial Fibrillation in Patients with Hypertrophic Cardiomyopathy

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial focuses on patients with hypertrophic cardiomyopathy (HCM), a common genetic heart disease characterized by thickened heart muscles. The study aims to explore different strategies to prevent the recurrence of atrial fibrillation (AF)</b), a condition where the heart beats irregularly, in patients diagnosed with HCM. AF is a frequent complication in HCM patients and can lead to serious health issues like stroke and heart failure. The trial will compare three treatment strategies: one involving an invasive procedure called early ablation, and two others based on medication. The medications being studied include amiodarone, a drug used to treat and prevent certain types of irregular heartbeats, and beta-blockers such as bisoprolol fumarate, metoprolol tartrate, and sotalol hydrochloride, which help manage heart rhythm and reduce blood pressure.

The study will involve 725 patients with HCM, and 300 of these patients who have experienced an episode of AF lasting more than 30 seconds will participate in the treatment phase. The goal is to determine which strategy is most effective in preventing AF recurrence. Participants will be monitored over a period of time to assess the impact of these treatments on their heart health and overall quality of life. The study will also look at the occurrence of other heart-related issues, such as ventricular arrhythmias, which are abnormal heart rhythms originating from the lower chambers of the heart, and any new changes in the brain detected by MRI scans.

By comparing these treatment strategies, the study aims to provide valuable insights into managing AF in patients with HCM, potentially improving their long-term health outcomes. The trial will run until 2029, allowing for comprehensive data collection and analysis to support its findings.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient is diagnosed with hypertrophic cardiomyopathy (HCM) as defined by the European Society of Cardiology.

    The patient must be 18 years of age or older and provide signed informed consent to participate in the study.

  2. Step 2

    Observation phase

    During this phase, 725 patients with HCM are observed to identify those with documented episodes of atrial fibrillation (AF) lasting more than 30 seconds.

    This phase helps determine eligibility for the next stage of the trial.

  3. Step 3

    Randomized therapeutic intervention phase

    300 patients with documented AF are selected for this phase.

    The study aims to compare three strategies to prevent the recurrence of AF in patients with HCM.

  4. Step 4

    Pharmacotherapy strategy 1

    Patients may receive amiodarone, a medication used to treat and prevent certain types of irregular heartbeats.

    The dosage and frequency of administration are determined by the study protocol.

  5. Step 5

    Pharmacotherapy strategy 2

    Patients may receive a beta-blocker or sotalol, which are medications used to manage abnormal heart rhythms.

    The specific medication, dosage, and frequency are determined by the study protocol.

  6. Step 6

    Early ablation strategy

    Patients may undergo an invasive procedure called ablation to prevent AF recurrence.

    This procedure involves targeting and destroying small areas of heart tissue that cause irregular heartbeats.

  7. Step 7

    Follow-up and assessment

    Patients are monitored for primary endpoints such as death, stroke, or unscheduled medical interventions.

    Secondary endpoints include AF load, occurrence of silent AF, ventricular arrhythmias, and changes in quality of life.

  8. Step 8

    Study completion

    The estimated end date for the study is March 31, 2029.

    The results will help determine the most effective strategy for preventing AF recurrence in patients with HCM.

Who can join the trial?

3 criteria

  • The patient must have been diagnosed with hypertrophic cardiomyopathy (HCM). This is a condition where the heart muscle becomes thickened, which can make it harder for the heart to pump blood.
  • The patient must have signed an informed consent form. This means they agree to participate in the study after being informed about what it involves.
  • The patient must be 18 years of age or older.

Who cannot join the trial?

8 criteria

  • Patients who have a heart condition called hypertrophic cardiomyopathy (HCM) with a history of atrial fibrillation (AF) episodes lasting more than 30 seconds.
  • Individuals who have significant enlargement of the left atrium, which is a part of the heart.
  • Patients who cannot take certain heart medications, such as antiarrhythmic drugs, due to other health issues.
  • People who have already undergone a procedure called percutaneous ablation for AF, which is a treatment to correct heart rhythm problems.
  • Individuals who are unable to follow the study procedures or take the required medications.
  • Patients with other serious health conditions that might interfere with the study or pose a risk to their safety.
  • Women who are pregnant or breastfeeding.
  • Individuals who are participating in another clinical trial at the same time.
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Investigated drugs

  • Amiodarone

    is a medication used to help control irregular heartbeats. In this trial, it is being tested to see if it can prevent the recurrence of atrial fibrillation in patients with hypertrophic cardiomyopathy.

  • Beta-blockers

    are a group of medications that help slow down the heart rate and reduce blood pressure. They are being used in this trial to see if they can prevent atrial fibrillation in patients with hypertrophic cardiomyopathy.

  • Sotalol

    is a medication that helps regulate heart rhythm. It is being tested in this trial to determine its effectiveness in preventing atrial fibrillation in patients with hypertrophic cardiomyopathy.

  • Ablation

    is a procedure that involves using energy to create small scars in the heart tissue to block abnormal electrical signals. This trial is investigating whether early ablation can prevent the recurrence of atrial fibrillation in patients with hypertrophic cardiomyopathy.

What is already known about the treatment

  • Amiodarone

    Amiodarone is administered orally or intravenously and is used to manage and prevent various types of irregular heartbeats, particularly atrial fibrillation. It is well-documented in medical literature as an effective antiarrhythmic medication. The main therapeutic indication for amiodarone is to restore and maintain a normal heart rhythm in patients with arrhythmias. At the molecular level, it works by blocking certain electrical signals in the heart that can cause an irregular heartbeat. Amiodarone is classified as a Class III antiarrhythmic agent.

  • Beta-blockers

    Beta-blockers are typically taken orally and are used to manage heart conditions such as high blood pressure and irregular heartbeats, including atrial fibrillation. They are widely recognized in medical literature for their effectiveness in reducing heart rate and blood pressure. The primary therapeutic indication is to control heart rhythm and reduce the risk of complications in patients with heart conditions. Beta-blockers work by blocking the effects of adrenaline on the heart, which helps to slow down the heart rate and reduce blood pressure. They belong to the pharmacological class of beta-adrenergic blocking agents.

  • Sotalol

    Sotalol is administered orally and is used to treat and prevent irregular heartbeats, particularly atrial fibrillation. It is well-established in medical literature as an effective antiarrhythmic medication. The main therapeutic indication for sotalol is to maintain a regular heart rhythm in patients with arrhythmias. At the molecular level, it works by blocking potassium channels in the heart, which helps to stabilize the heart's electrical activity. Sotalol is classified as a Class III antiarrhythmic agent.

Investigated diseases

Hypertrophic Cardiomyopathy (HCM) – Hypertrophic cardiomyopathy is a genetic heart condition characterized by the thickening of the heart muscle, particularly affecting the left ventricle. This thickening can occur without an obvious cause, such as high blood pressure or intense athletic training. The condition can vary greatly in its presentation, with some individuals experiencing significant symptoms while others may have none. It is often inherited in an autosomal dominant pattern and is linked to mutations in genes responsible for heart muscle proteins. HCM can lead to complications such as atrial fibrillation, which is a common arrhythmia in these patients. The disease affects people of all ethnicities and genders equally, with an estimated prevalence of 1 in 500 to 1 in 200 people globally.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508743-43-00Protocol codeFLC.IV/X/22Estimated enrolment725 patientsSponsorNarodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

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