2022-500814-24-00招募中3 期
An Investigator-Initiated Prospective Randomized Open-Label Blinded-Endpoint Crossover Trial Comparing the Effect and Safety of Flecainide and Metoprolol versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse (FLECAPRO).
Oslo University Hospital Hf1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年9月27日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of ventricular tachyarrhythmias, composite of: a) Ventricular tachycardia b) Ventricular fibrillation.
研究概览
简要总结
The main objective is to evaluate the effect and safety of adding flecainide to standard beta blocker therapy to reduce burden of ventricular arrhythmias in patients with arrhythmic mitral valve prolapse.
研究设计
- 分配方式
- Randomized
- 主要目的
- Main Study
- 盲法
- Single (Analyst)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Participants must be 18 years of age or older at the time of signing the informed consent.
- •Participants must have mitral valve prolapse evident by echocardiography or cardiac magnetic resonance imaging, defined as more than or equal to 2 mm atrial displacement of any part of the mitral leaflets.
- •Participants must have ventricular arrhythmias, defined as at least one of the following: a) Premature ventricular complex burden ≥3% per 24-hours by Holter monitoring b) Premature ventricular complex burden ≥1% per 24-hours if multifocal or occurring in bi-/trigemini and/or couplets by Holter monitoring c) Sustained or non-sustained ventricular tachycardia d) Aborted cardiac arrest
- •Participants must have a clinical indication for antiarrhythmic therapy due to ventricular arrhythmias.
- •Participants must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).
- •Participants must accede to mandatory use of a contraceptive method for the duration of the trial and until 3 days after discontinuation of study medication.
排除标准
- •Strict contraindication for flecaininde or metoprolol.
- •More than moderate vavular disease according to international guidelines
- •Pre-excitation syndrome
- •Any degree of AV-block, except due to enchanced vagal tone (e.g. Wencheback-block at night in young athletes or 1st degree AV-block that disappears during exercise)
- •Bundle branch block (QRS duration >120 ms) or intraventricular conduction defect with QRS >120 ms.
- •Prior flecainide therapy
- •Concomitant use of the following medications: a) CYP2D6 inhibitors/inducers. b) Class I, III or IV antiarrhythmic drugs. c) Clozapine, quinidine, cimetidine bupropion. d) Monoaminoxydase (MAO) inhibitors.
- •Not willing to use a mandatory contraceptive method for the duration of the trial
- •Heart failure (signs or symptoms, elevated NT-proBNP) according to ICD10
- •Abnormal liver or kidney function (AST/ALT three times upper normal, eGFR<60)
- •Prior myocardial infarction or ischemic heart diease
- •Ion channelopathy, including Brugada syndrome and long QT syndrome, according to ICD10 and ECG
- •Genetic cardiomyopathy (hypertrophic cardiomyopathy, arrhythmogenic cardiomyopathy, dilated cardiomyopathy, including genotype positive phenotype negative individuals)
- •Atrial flutter or permanent atrial fibrillation according to ICD10 an ECG
- •Sinus node dysfunction according to ICD10 and ECG
- •Ongoing electrolyte disorders
结局指标
主要结局
Number of ventricular tachyarrhythmias, composite of: a) Ventricular tachycardia b) Ventricular fibrillation.
Number of ventricular tachyarrhythmias, composite of: a) Ventricular tachycardia b) Ventricular fibrillation.
次要结局
- Burden of premature ventricular complexes (by 24-hour Holter monitoring)
- Health-related quality of life (number of patients with ≥5 points increase in SF-36 overall summary score)
- Number of severe ventricular tachycardias, composite of: a) Non-sustained ventricular tachycardia with syncope b) Sustained ventricular tachycardia c) Ventricular fibrillation
研究者
Eivind Westrum Aabel
Scientific
Oslo University Hospital Hf
研究点 (1)
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