2024-511190-30-00招募中2 期
The QUEEN-IVF trial: Quinidine versus verapamil in short-coupled idiopathic ventricular fibrillation: An open-label, randomized crossover pilot trial
Amsterdam UMC7 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年2月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 7
- 主要终点
- The primary endpoint is sustained ventricular arrhythmia, assessed using the severity scoring system. A subject will be scored in each treatment period according to the scoring system by the ECC. The highest applicable score will be used
研究概览
简要总结
The objective of this study is to determine the advisability and feasibility of a definitive RCT that will assess quinidine as compared with verapamil in patients with short-coupled IVF in terms of the safety and efficacy with regard to arrhythmic events.
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
- •At least one of the following 3 principal diagnostic criteria for short-coupled IVF: A. Diagnosis of short-coupled IVF, based on any documentation (i.e., 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 B. Isolated PVCs with a coupling interval <350 ms during the index admission after SCA based on a shockable rhythm or (presumed) arrhythmogenic syncope C. DPP6 haplotype carrier
- •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, genes other 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
- •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 shortcoupled 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 electrophysiological findings similar to short-coupled IVF
- •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 procedure
- •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 subjects
- •Circumstances that prevent follow-up
- •Inability to take orally administered tablets
- •Current treatment with class 1 antiarrhythmic medication (other than quinidine), class 3 antiarrhythmic medication, or digoxin, unless this medication is discontinued; patients who are currently treated with amiodarone will not be included due to the long elimination half-life of amiodarone, unless amiodarone was only administered intravenously for a short period of time
- •Inability to provide informed consent
- •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 7.6)
- •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 ryanodine receptor 2 (RYR2) mutation
- •Presence of ischemia-induced short-coupled ventricular arrhythmia in patient with documented coronary spasm
结局指标
主要结局
The primary endpoint is sustained ventricular arrhythmia, assessed using the severity scoring system. A subject will be scored in each treatment period according to the scoring system by the ECC. The highest applicable score will be used
The primary endpoint is sustained ventricular arrhythmia, assessed using the severity scoring system. A subject will be scored in each treatment period according to the scoring system by the ECC. The highest applicable score will be used
次要结局
未报告次要终点
研究者
Christian van der Werf
Scientific
Amsterdam UMC
研究点 (7)
Loading locations...
相似试验
招募中
4 期
RAndom sTArT Ovarian stimUlatIon (RSOS) in eLective oocyte cryopreservation cycLEs (RATATOUILLE): a single-center, non-inferiority, randomised controlled trial2023-509919-89-00UZ Brussel277
招募中
3 期
A RANDOMIZED, OPEN-LABEL PHASE 3 STUDY IN PATIENTS WITH PREVIOUSLY TREATED UNRESECTABLE OR METASTATIC NRAS MUTANT CUTANEOUS MELANOMA COMPARING THE COMBINATION OF NAPORAFENIB + TRAMETINIB TO PHYSICIAN’S CHOICE OF THERAPY (DACARBAZINE, TEMOZOLOMIDE OR TRAMETINIB MONOTHERAPY) WITH A DOSE OPTIMIZATION LEAD-IN [SEACRAFT-2]2024-511404-17-00Erasca Inc.294
招募中
3 期
Efficacy of certolizumab in women with unexplained recurrent implantation failure: a double-blind randomized controlled trial (CERTIFY)2024-511869-11-00Assistance Publique Hopitaux De Paris161
招募中
2 期
Phase II Study Evaluating Ivosidenib Maintenance After SOC Adjuvant Chemotherapy in Curative mIDH1 CholangiocarcinomaCholangiocarcinomaCholangiocarcinomaNCT07260175Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest40
招募中
3 期
A Study to Select a Dose Regimen (Part A) and to Investigate Overall Survival (Part B) With Nanvuranlat Compared With Physician's Best Choice in Participants Aged 18 Years or Older With Biliary Tract CancerNCT07265674J-Pharma Co., Ltd.480