Early ablation of atrial fibrillation in patients with hypertrophic cardiomyopathy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 725
- 试验地点
- 1
- 主要终点
- 1. death or 2. stroke / TIA or 3. extra-scheduled medical intervention defined as: hospitalization / emergency room / emergency room visit / medical visit
研究概览
简要总结
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.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •1.diagnosed hypertrophic cardiomyopathy as defined by the European Society of Cardiology,
- •signed informed consent to participate in the study,
- •18 years of age or more
排除标准
- •age <18 years of age,
- •permanent atrial fibrillation,
- •previous treatment with amiodarone,
- •absolute contraindications to ablation treatment or absolute contraindications to amiodarone administration,
- •left atrium size in short axis echocardiography > 5.5 cm or four-chamber view LA area> 35 cm2,
- •NYHA class IV heart failure,
- •double-determined left ventricular ejection fraction <30% despite optimal treatment; including at least 1 record on sinus rhythm,
- •pregnancy or breastfeeding,
- •participation in another clinical trial,
- •expected non-compliance during the study,
- •absolute contraindication to magnetic resonance imaging,
- •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)
结局指标
主要结局
1. death or 2. stroke / TIA or 3. extra-scheduled medical intervention defined as: hospitalization / emergency room / emergency room visit / medical visit
1. death or 2. stroke / TIA or 3. extra-scheduled medical intervention defined as: hospitalization / emergency room / emergency room visit / medical visit
次要结局
- 1. atrial fibrillation load> 12 hours during any observation day, 2. mean fibrillation load during the follow-up period, 4. occurrence of silent AF in the HCM patient population, 5. occurrence of ventricular arrhythmias, including non-sustained ventricular tachycardia, 6. new ischemic changes in CNS MRI, 7. correlation of changes in MRI of the CNS with the AF burden, and: 8. change in quality of life assessed by the SF-36 questionnaire before and after one year after randomization.
研究者
Lukasz Szumowski
Scientific
Narodowy Instytut Kardiologii Stefana Kardynala Wyszynskiego Panstwowy Instytut Badawczy