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

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What is this study about?

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.

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 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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name City Country Status
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy Warsaw Poland

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

Trial status

Country Status Recruitment Start
Poland Poland
Not recruiting
01.01.2024

Trial locations

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.

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 ID:
2023-508743-43-00
Protocol code:
FLC.IV/X/22
Trial Phase:
Therapeutic confirmatory (Phase III)

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