NL-OMON55988招募中2 期
Quinidine versus verapamil in short-coupled idiopathic ventricular fibrillation: An open label, randomized crossover pilot trial. - QUEEN-IVF
Amsterdam UMC0 个研究点目标入组 35 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 35
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 99（—）
入选标准
- •At least one of the following 3 principal diagnostic criteria for
- •short-coupled VF:
- •1. Diagnosis of short-coupled IVF, based on any documentation (through
- •electrocardiogram (ECG), Holter monitor, device electrogram (EGM), or
- •telemetry) of PVT of >=3 consecutive beats or VF initiated by a PVC with a
- •coupling interval <350 ms
- •2. Isolated PVCs with a coupling interval <350 ms during the index admission
- •after SCA based on a shockable rhythm or presumed arrhythmogenic syncope
- •3. DPP6 haplotype carrier (also without documentation of short-coupled IVF)
- •Functioning transvenous or subcutaneous ICD in place
- •Sudden cardiac arrest, (near)syncope, appropriate ICD shock or nonsustained
- •PVT documented by the ICD at least once in the past 2 years
- •Genetic testing has been initiated. Results are not required to be known at
- •the time of inclusion. In subjects who are family members of DPP6 carrying
- •index patients, others genes than DPP6 are not required to be tested.
- •Willing to undergo two assigned treatment periods with verapamil and quinidine
- •Age >= 18 years
排除标准
- •Pregnancy or lactation
- •Current treatment with amiodarone
- •Patients with a history of therapy refractory ventricular arrhythmia on an
- •adequate dose of verapamil or quinidine, as determined by the treating
- •cardiologist.
- •Contra-indication to quinidine or verapamil (see section 7.5)
- •Significant structural heart disease (left ventricular ejection fraction
- •<50%, suspicion or definitive diagnosis of cardiomyopathy, moderate/severe
- •pulmonary, mitral, or aortic valve stenosis or 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
- •Presence of a pathogenic or likely-pathogenic RYR2 mutation. DPP6 carrier
- •family members are not required to be tested for RYR2 carrier status.
- •Presence of ischemia-induced short-coupled ventricular arrhythmia in patient
- •with documented coronary spasm
- •Presence of pause-dependent torsade de pointes [preceding R-R interval prior
- •to the trigger PVC >1500 ms in individuals without pacemaker/ICD or >1300 ms in
- •individuals with pacemaker/ICD] following a stable baseline rhythm. Initiation
- •of ventricular arrhythmia by short-long-short cycles (R-R cycles <1300 ms) with
- •a short-coupled trigger PVC is allowed
- •Significant coronary artery disease (>=50% narrowing of the diameter of the
- •lumen of the left main coronary artery or >=70% narrowing of the diameter of the
- •lumen of the left anterior descending coronary artery, left circumflex artery
- •or right coronary artery)
- •Reversible metabolic or pharmacological/toxicological conditions that may
- •cause similar electrophysiological findings
- •Patients who are considered electrically unstable, at physician*s discretion,
- •due to active electrical storm or very frequent nonsustained episodes of
- •short-coupled IVF requiring intravenous or invasive therapy
- •Successful radiofrequency ablation of the PVC initiating short-coupled IVF
- •and absence of documented (non)sustained episodes of short-coupled PVT/VF
- •afterwards. The patient will, however, be eligible to participate in the study
- •if >= 1 episode of short-coupled PVT/VF is documented after the ablation
- •Intention to perform radiofrequency ablation of the PVC initiating
- •short-coupled IVF during the course of the study
- •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
- •Circumstances that prevent follow-up
- •Is unable to take orally administered tablets
- •Inability to provide informed consent
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