NCT02932007招募中2 期
Chloroquine for Patients With Symptomatic Persistent Atrial Fibrillation: A Prospective Pilot Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of patients with termination of AF
研究概览
简要总结
The goal of this pilot study is to explore the efficacy of chloroquine in terminating persistent AF and assess its potential role as a pharmacological cardioversion agent for the management of AF.
详细描述
This is an open-label, pilot study to explore the efficacy of chloroquine in terminating persistent AF within 2 weeks of drug administration and assess its potential role as a pharmacological cardioversion agent for the management of AF. Subjects will be followed for 2 weeks from the start of drug administration to study drug termination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •History of symptomatic persistent AF Persistent AF - defined as continuous AF that is sustained more than 7 days but less than 12 months. Episodes of AF of ≥ 48 hours duration in which a decision is made to terminate with electrical or pharmacological cardioversion prior to 7 days will also be classified as persistent AF
- •AF must be documented at least once either by ECG, event monitoring, loop recorder, telemetry, trans-telephonic monitoring, pacemaker or cardiac defibrillator readouts within 24 months prior to enrollment
- •Currently on anticoagulation therapy as indicated per local guidelines, which is considered optimal for stroke prevention in the opinion of the investigator
- •Implanted dual chamber pacemaker/ICD capable of monitoring atrial arrhythmias or willingness to wear a 2 weeks event monitor if patient does not have a device capable of monitoring atrial arrhythmias
- •Signed informed consent
排除标准
- •Age < 18 years
- •AF felt to be secondary to an obvious reversible cause such as, but not limited to, acute myocardial infarction, pulmonary embolism, recent surgery, pericarditis, alcohol intoxication, hypoxemia, or thyrotoxicosis
- •Structural heart disease including patients with artificial heart valves or valvular AF
- •Obstructive coronary artery disease or history of any myocardial infarction
- •Ejection fraction < 50% within 1 year of consent
- •Severe or moderate to severe aortic stenosis, mitral stenosis, aortic regurgitation, or mitral regurgitation per PI discretion
- •Prolonged QTc of >460 msec on baseline ECG
- •Contraindications to quinolines
- •Known allergy or hypersensitivity to Chloroquine
- •Use of amiodarone 12 months prior to enrollment
- •History of AF ablation within 30 days prior to enrollment
- •Renal impairment (eGFR < 30 mL/min/1.73 m2 or Serum Creatinine > 1.25 mg/dL) for subjects over the age of 65
- •Hepatic disease (ALT/AST 2X the upper normal limit)
- •History of alcohol abuse and/or drug abuse per PI discretion
- •Pre-existing auditory damage
- •History of epilepsy
- •Women of child-bearing potential (those who have had a menstrual period in the previous 12 months) who:
- •are pregnant or breast-feeding or plan to become pregnant during study or
- •who are not surgically sterile and are not practicing two acceptable methods of birth control, or do not plan to continue practicing two acceptable methods of birth control throughout the study (highly effective methods are listed under section 6.0 Pregnancy)
- •Current participation in another clinical study
- •Serious or active medical or psychiatric condition which, in the opinion of the investigator, may interfere with treatment, assessment, or compliance with the protocol
- •Not able to discontinue medications known to have significant interactions with chloroquine
研究组 & 干预措施
Chloroquine Phosphate
Experimental
Chloroquine Phosphate will be provided at 500 mg dosage strength for oral administration. Patient will be instructed to take 2 tablets per day on the first two days and 1 tablet each day for the next 12 days for a total of 14 days treatment.
干预措施: Chloroquine Phosphate (Drug)
结局指标
主要结局
Proportion of patients with termination of AF
时间窗: Within 2 weeks of study drug initiation
次要结局
- Percentage of AF burden(Within 2 weeks of study drug initiation)
- QT intervals(Within 2 weeks of study drug initiation)
- Time to AF termination(Within 2 weeks of study drug initiation)
- Percentages of classifications of rhythms identified(Within 2 weeks of study drug initiation)
- PR interval(Within 2 weeks of study drug initiation)
- QRS duration(Within 2 weeks of study drug initiation)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Therapeutic Efficacy of Chloroquine Plus Primaquine in the Treatment of Uncomplicated Plasmodium VivaxEfficacyMalariaChloroquineVivax MalariaNCT06044805Dinka Dugassa100
已完成
4 期
Extended-dose Chloroquine (ECQ) for Resistant Falciparum Malaria Among Afghan Refugees in PakistanMalaria, FalciparumNCT01019408London School of Hygiene and Tropical Medicine163
已完成
不适用
Chloroquine/ Hydroxychloroquine Prevention of Coronavirus Disease (COVID-19) in the Healthcare SettingCOVID19CoronavirusAcute Respiratory IllnessesNCT04303507University of Oxford4,652
Unknown
1 期
The Effect of Chloroquine in the Treatment of Patients With DengueDengueNCT00849602University of Sao Paulo132
终止
1 期
Study to Explore the Effect of Mefloquine in Participants With Progressive Multifocal Leukoencephalopathy (PML)Progressive Multifocal LeukoencephalopathyNCT00746941Biogen37