Ended Therapeutic use (Phase IV) 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.

Early ablation of atrial fibrillation in patients with hypertrophic cardiomyopathy

Q: Do participants get paid in this trial?

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Q: Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

Q: How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Q: Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

EU CTIS ID: 2023-508743-43-00

What this study is testing

The aim of the study is to compare 3 strategies (2 based on pharmacotherapy and invasive methods of early ablation) to prevent recurrence of atrial fibrillation (AF) in patients diagnosed with hypertrophic cardiomyopathy (HCM). more effective than two alternative pharmacotherapy strategies compared in the study: 1. use of amiodarone or 2. only beta-blocker or sotalol. Population: 725 patients diagnosed with HCM will be included in the observation phase of the study and subsequently 300 with documented AF > 30 sec. episode will be included in randomized therapeutic intervention phase.

Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1.diagnosed hypertrophic cardiomyopathy as defined by the European Society of Cardiology, 2. signed informed consent to participate in the study, 3. 18 years of age or more

You likely can't join if

1. age <18 years of age, 2. permanent atrial fibrillation, 3. previous treatment with amiodarone, 4. absolute contraindications to ablation treatment or absolute contraindications to amiodarone administration, 5. left atrium size in short axis echocardiography > 5.5 cm or four-chamber view LA area> 35 cm2, 6. NYHA class IV heart failure, 7. double-determined left ventricular ejection fraction <30% despite optimal treatment; including at least 1 record on sinus rhythm, 8. pregnancy or breastfeeding, 9. participation in another clinical trial, 10. expected non-compliance during the study, 11. absolute contraindication to magnetic resonance imaging, 12. other important reason which, due to the researcher opinion, does not qualify the patient to participate in the study 13.Lack of consent to use contraception during the study and during the obligatory period to use contraception after the study for one month. 14.Decompensated thyroid dysfunction 15.• Indication for simultaneous use of drugs that prolong the QT interval ((class Ia antiarrhythmic drugs, e.g.: quinidine, procainamide, disopyramide; class III antiarrhythmic drugs, e.g. sotalol, bretylium; erythromycin, cotrimoxazole, pentamidine; some antipsychotics or antidepressants, e.g. chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpride and sertindole; lithium preparations and tricyclic drugs, e.g. doxepin, maprotiline, amitriptyline, some antihistamines, e.g. terfenadine, astemizole, mizolastine)

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.

Find trials near you

This trial is registered in the EU. Search recruiting trials near you for 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. - answer a few quick questions and apply in minutes.

Full record on EU CTIS

SponsorNarodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy

Target enrollment725

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.