The Effect of Nifedipine Versus Telmisartan on Prevention of Atrial Fibrillation Recurrence in Hypertensive Patients With Paroxysmal Atrial Fibrillation by Intensive Lower Blood Pressure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Recurrence of Atrial Fibrillation
研究概览
简要总结
Different lowing blood pressure strategies have a different clinical efficacies. Blocking the angiotensin II type 1 receptor (Telmisartan) reduces the incidence of episodes of atrial fibrillation in hypertensive patients with paroxysmal atrial fibrillation during 24 months than 30% compared to Nifedipine( Adalat GITS ).
A total of 160 subjects will be included in two study groups. The Group 1 will receive 80-160mg Telmisartan per day, the remaining patients will receive Nifedipine ( Adalat GITS). Follow-up is 24 months. The conventional 12-lead ECG recordings at twice weeks interval and 24hrs holter monitor will determine the cardiac rhythm and asymptomatic episodes of atrial fibrillation. The target of Blood pressure after 3 months is less than 130/80mmHg. Concomitant therapy with B-blocker and acethydrazide are allowed for the target blood pressure during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented hypertensive patients with paroxysmal atrial fibrillation: ECG documentation of atrial fibrillation at least in one ECG recorded during the last 2 months prior to randomization plus additional ECG recording of sinus rhythm at least 12 hours after the above mentioned ECG documentation.
- •Patients with hypertensive history were at least 5 years. Systolic pressure > 140mmHg, < 190mmHg, Diastolic pressure > 85mmHg. < 110mmHg.
- •40 < Age < 65 years
排除标准
- •Strong clinical evidence for therapy with AT II/ACE inhibitors before 3 months of screening
- •Therapy with antiarrhythmic agents of class I or class III within the last month, therapy with amiodarone within the last 3 months
- •Direct current (DC) cardioversion within the last 3 months
- •Symptomatic bradycardia
- •Implanted pacemaker or implanted cardioverter/defibrillator with any antitachycardiac algorithm in use
- •Cardiac surgery or cardiac catheter ablation within the last 3 months
- •Typical angina pectoris symptoms at rest or during exercise
- •Known coronary artery disease with indication for intervention
- •Valvular disease > II degree
- •Left ventricular ejection fraction < 40%
- •Diastolic blood pressure > 110mm Hg at rest
- •Symptomatic arterial hypotension
- •Known renal artery stenosis
- •Serum creatinine > 1.8 mval/l
- •Relevant hepatic or pulmonary disorders
- •Hyperthyroidism manifested clinically and in laboratory
- •Known drug intolerance for AT II inhibitors
- •Females who are pregnant or breast feeding
- •Females of childbearing potential who are not using a scientifically accepted method of contraception
- •Participation in a clinical trial within the last 30 days
- •Drug addiction or chronic alcohol abuse
- •Legal incapacity, or other circumstances which would prevent the patient from understanding the aim, nature or extent of the clinical study
- •Evidence of an uncooperative attitude
研究组 & 干预措施
Nifedipine
Patients in arm 1 receive Nifedipine;
干预措施: Nifedipine, (Drug)
Telmisartan
Arm 2 receive telmisartan
干预措施: Telmisartan (Drug)
结局指标
主要结局
Recurrence of Atrial Fibrillation
时间窗: four years
Recurrence of Atrial Fibrillation ( at least one readable conventional and Holter ECG recording)
次要结局
未报告次要终点
研究者
Yuehui Yin
Chief, Dept. of Cardiology, the second affiliated hospital of Chongqing medical university
The Second Affiliated Hospital of Chongqing Medical University