2024-514113-35-01招募中4 期
Multicenter randomized clinical trial to evaluate two different amiodarone regimens to maintain sinus rhythm after cardioversion in persistent atrial fibrillation (PERIVERSION-2).
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau4 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2025年1月27日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 4
- 主要终点
- First recurrence of AF (requires ECG) after randomization.
研究概览
简要总结
To compare the efficacy in maintaining sinus rhythm 12 months post electrical cardioversion between standard (200 mg/d) and reduced (100 mg/d) doses of amiodarone in patients with persistent atrial fibrillation.
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
- •Patients aged ≥ 18 ye
- •Documented persistent atrial fibrillation (≥ 7 days in duration)
- •Electively referred for Electrical Cardioversion under amiodarone treatment
- •Signed informed consent
排除标准
- •Urgent electrical cardioversion
- •Significant left ventricular hypertrophy (wall thickness ≥ 15mm)
- •Hyperthyroidism or hypothyroidism
- •Known hepatobiliary disease (acute hepatitis, cirrhosis...) or ALT/AST > 3 x upper limit of normal (ULN)
- •Allergy, intolerance, or known hypersensitivity to study medications
- •Patients with contraindications to amiodarone, such as uncontrolled thyroid dysfunction, severe sinus bradycardia, second- or third-degree AV block without a pacemaker, and a history of amiodarone-induced pulmonary toxicity.
- •Women of childbearing potential unwilling to use contraceptive measures and breastfeeding women.
- •Participation in another clinical trial involving investigational drugs
- •Life expectancy less than 12 months
- •Rheumatic mitral stenosis of any degree or severe mitral or aortic valve dysfunction.
- •Atrial fibrillation post-cardiac surgery
- •Previous myocardial infarction
- •New York Heart Association (NYHA) Class IV heart failure
- •Left ventricular ejection fraction (LVEF) <45%
结局指标
主要结局
First recurrence of AF (requires ECG) after randomization.
First recurrence of AF (requires ECG) after randomization.
次要结局
- Assessment of adverse effects, which will be determined by specific criteria including TSH levels below 0.1 microUI/ml, TSH levels exceeding 4.2 microUI/ml, a threefold increase in AST, ALT, or GGT compared to baseline levels, a QTc interval exceeding 500 ms or any other adverse effects as per the drug technical sheet.
- Study of polymorphisms in CYP2D6, CYP2C19, CYP1A2, CYP2C8, CYP3A4, and ABCB1.
- Plasma levels of amiodarone during follow-up
- Correlate polymorphisms, with plasma levels, safety and efficacy.
研究者
UICEC Sant Pau
Scientific
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
研究点 (4)
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