跳至主要内容
临床试验/CTIS2024-510682-42-01
CTIS2024-510682-42-01进行中(未招募)1 期

Optimal drug therapy for the suppression of ventricular arrhythmias in Andersen-Tawil syndrome and multifocal ectopic Purkinje-related premature contractions: a series of N-of-1 trials

Amsterdam UMC0 个研究点目标入组 10 人开始时间: 2024年3月4日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
10

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • One of the following two primary diagnostic criteria A.Clinical diagnosis of ATS. Genetically confirmed diagnosis (i.e. class 4 or 5 KCNJ2 variant) is not required B.Clinical diagnosis of MEPPC and carrier of associated class 4 or 5 SCN5A variant, Has demonstrated a disease phenotype of ATS or MEPPC including ventricular arrhythmia burden at any point during follow-up on Holter monitor or other rhythm monitoring device (i.e. loop recorder, ECG patch), Is currently treated with a stable (at least 3 months) dose of flecainide, Age = 18 years

排除标准

  • Pregnancy, Inability to take orally administered tablets, Inability to provide informed consent, Contra-indication to study medication, Significant structural heart disease (left ventricular ejection fraction <50%, history or signs of coronary ischemia, suspicion or definitive diagnosis of cardiomyopathy, or moderate/severe valve regurgitation), Suspicion or definitive diagnosis of another (heritable) arrhythmia syndrome, e.g. Brugada syndrome, early repolarization syndrome or catecholaminergic polymorphic ventricular tachycardia, Presence of a short (<350 ms) or prolonged (>480 ms) heart-rate corrected QT interval on the resting ECG at baseline, History of therapy refractory ventricular arrhythmia or intolerable side-effects on an adequate dose of any study medication, as determined by the treating cardiologist, Serious known comorbid disease with a life expectancy of less than two years, Ongoing medical condition that is deemed by the principal investigator to interfere with the conduct or assessments of the study or safety of the subjects, Circumstances that prevent follow-up

研究者

发起方
Amsterdam UMC

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