Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Early ablation of atrial fibrillation in patients with hypertrophic cardiomyopathy

This study is investigating whether treating an irregular heartbeat called atrial fibrillation (AF) early in patients with a heart condition called hypertrophic cardiomyopathy (HCM) can improve their health. HCM is an inherited condition where the heart muscle thickens, affecting about 1 in 200 people. AF is a common complication in HCM patients and can lead to serious problems like stroke, worsening heart failure, or even sudden cardiac death. Doctors are trying to see if an early procedure called ablation, which uses energy to correct the heart's rhythm, can prevent these serious issues. The study aims to compare this early treatment approach with standard care to understand its benefits and risks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Enrolment target

725

Start

04 Mar 2024

Hypertrophic cardiomyopathy (HCM) is the most common genetically determined disease of the heart characterized by a varied picture and clinical course. The first comprehensive clinical description of the disease comes from the 1960s. Currently the disease is diagnosed on the basis of a phenotypic picture showing left ventricular hypertrophy which cannot be explained by the increased hemodymamic overload only. Observed hypertrophy (up to 30 to 50 mm) in some cases presents smaller (from 13 to 7 / 70 14 mm among family members)what may sometimes require differentiation from hypertrophy secondary to arterial hypertension or the physiological athlete heart phenomenon. Epidemiological studies have shown the incidence of the disease 1 per 500 people in the general population but taking into account the clinical and genetic diagnosis the incidence may reach even 1 per 200. It can be estimated that in Poland about 100 000 people may be affected by HCM and only a part of them is diagnosed mostly using imaging methods. Worldwide HCM is likely to affect around 20 million people come across a wide range of ethnicities and races and affects both genders equally. Hypertrophic cardiomyopathy is an inherited disease in an autosomal dominant manner and is most often associated with mutations in one of described several genes coding for sarcomere proteins. Atrial fibrillation (AF) occurs in 20-25% of patients with hypertrophic cardiomyopathy and the annual incidence of AF in HCM ranges from 2% to 3%. the reference center was 25.5%. The incidence of AF in patients with hypertrophic cardiomyopathy under 65 years of age in own data of the National Institute of Cardiology was found to be as high as 25.5%. In elderly population AF occurence is even higher with respect to the high frequency and importance of this clinical problem for highly specialized centers. Due to the development of technologies for continuous ECG monitoring and the resulting changes in the sensitivity and specificity of AF diagnosis the real AF occurrence in the population with HCM may be as high as 40-50%. At the same time current studies indicate that AF significantly affects the prognosis of patients with HCM and the occurrence of any form of AF is associated with a significantly increased risk of systemic embolism (including CNS stroke) [relative risk (RR) 7.0 95% CI 4.6-10.7]heart failure progression (RR 2.8 95% CI 1.6-4.6)sudden cardiac death (RR 1.7 95% CI 1.3-2 3) and all-cause mortality (RR 2.5 95% CI 1.8-3.4) with a mean follow-up of 7 years. Hence preventing the development of AF in patients with HCM seems to be an important therapeutic goal in this group. According to the recommendations of the Cardiac Societies worldwide percutaneous ablation of AF can be considered in patients without significant left atrial enlargement who have symptoms despite treatment or who cannot take antiarrhythmic drugs or is a preferential choice. Currently there are no prospective randomized trials of antiarrhythmic drugs versus ablation what seems a significant limitation of all publications and recommendations regarding the treatment of AF in patients with HCM. The best and robust available registry data indicate that the initial attempt to maintain sinus rhythm with lifestyle modification and antiarrhythmic drugs is moderately successful and indicate potentially significant ablation efficacy especially in the early stage of AF development in patients with HCM. The rationale we present led to the design of the submitted study.

What is this study about?

This study focuses on a heart condition called hypertrophic cardiomyopathy (HCM). HCM is usually inherited and causes the heart muscle to thicken, making it harder for the heart to pump blood effectively. It affects around 1 in 200 people worldwide, though many might not even know they have it.

People with HCM often develop an irregular and rapid heartbeat called atrial fibrillation (AF). AF can be quite serious for those with HCM, as it significantly increases their risk of strokes, makes their heart failure worse, and can even lead to sudden cardiac death. Because of these risks, preventing or promptly treating AF is a really important goal for doctors looking after HCM patients.

Currently, there isn't a lot of strong research comparing different ways to treat AF in HCM patients. This study wants to find out if treating AF early with a procedure called ablation – which works by stopping the faulty electrical signals in the heart that cause AF – can help prevent serious health problems down the line. It's hoped that early intervention might make a big difference in the long-term health of people with HCM.

Key takeaways

Targets early AF treatment in HCM patients.
Aims to reduce stroke and heart complications.
Involves a procedure called ablation.
Compares early intervention with standard care.
Monitors health outcomes like stroke, hospital visits, and quality of life.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years of age or older. There is no upper age limit for joining.

Both men and women are welcome to take part in this research.

Essentially, if you are an adult with hypertrophic cardiomyopathy (HCM) and have atrial fibrillation (AF), you might be suitable for this study.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of hypertrophic cardiomyopathy (HCM)?
Do you have atrial fibrillation (AF)?
Are you willing to potentially undergo an ablation procedure?
Are you able to attend regular follow-up appointments and assessments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, doctors will be closely monitoring your health. The study will track serious events like death, stroke, or if you need an unexpected hospital visit or extra medical attention. They will also look at how often you experience atrial fibrillation, any silent episodes of AF, and other heart rhythm problems.

Regular check-ups will assess changes in your brain using MRI scans and your overall quality of life using a special survey before and one year after starting the study. You might be prescribed medications like Bisocard (various strengths, coated tablets), Cordarone (200 mg tablets), Betaloc ZOK (95 mg or 50 mg extended-release tablets), or SotaHEXAL (80 mg or 160 mg tablets), which are medicines commonly used to manage heart conditions. The total duration of your participation will involve follow-up for these events and assessments.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. You might benefit from closer medical monitoring and potentially an earlier treatment approach for your atrial fibrillation, which could reduce your risk of serious complications like stroke. However, there are always risks associated with medical procedures and medications. Your doctor will explain these in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Poland

Common questions

What is hypertrophic cardiomyopathy (HCM)?

HCM is an inherited heart condition where the heart muscle becomes thicker, making it harder for the heart to pump blood around your body.

What is atrial fibrillation (AF)?

AF is a common type of irregular and often rapid heartbeat that can increase your risk of strokes and other heart problems.

Why is early treatment of AF important in HCM patients?

For people with HCM, AF can significantly increase the risk of serious issues like stroke, worsening heart failure, and sudden cardiac death, so treating it early might help prevent these problems.

What is ablation?

Ablation is a procedure that uses energy to create tiny scars in the heart tissue to block faulty electrical signals that cause an irregular heartbeat like AF.

Will I have to take medication?

Yes, you might be prescribed medicines like Bisocard, Cordarone, Betaloc ZOK, or SotaHEXAL, which are standard treatments for heart rhythm problems.