NCT01233635终止4 期
Secondary Prevention of Atrial Fibrillation (Impact of Renin-Angiotensin-Aldosterone System Inhibition)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- AF burden
研究概览
简要总结
In the present application, we propose to refine and extend current insight into AAF mechanism and therapy by examining the importance of pharmacologic RAAS inhibition, ACE genotype, and their interaction in secondary AF prevention. We have 3 specific aims:
- To confirm that RAAS inhibition therapy reduces the incidence of AF recurrence.
- To test the hypothesis that the incidence of AF recurrence in the absence of RAAS inhibition therapy is higher among patients with the D allele.
- To explore the hypothesis that RAAS inhibition therapy is more effective for preventing AF recurrence in patients with the DD genotype than in those with DI or II genotypes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Subjects must be in atrial fibrillation confirmed by 12 lead EKG.
- •blood pressure > 90 mmHg
- •Patient without cardiopulmonary symptoms
- •18+ years of age
排除标准
- •Contraindiction to warfarin
- •Recent (within 6 months) MI or cardiac revascularization
- •Recent (within 6 months) CVA or TIA
- •NYHA Class IV CHF
- •Active thyroid disease
- •Major hepatic dysfunction
- •Renal dysfunction (>2 mg/dL)
- •Hyperkalemia (>4.6 mEq/L)
- •Hyponatremia (<130 mEq/L)
- •Currently taking a Vaughn-Williams Type I or III antiarrhythmic drug
- •History of ARB intolerance
- •Contraindication to ARB therapy
- •Pregnancy
- •Female of childbearing age
- •Age < 18 years of age
- •Inability to give informed consent
- •Other medical conditions calling 1 year survival into question
研究组 & 干预措施
A Group 1 no drug
Experimental
Patients who have not taken ACE/ARB, randomized to no drug.
干预措施: no drug (Other)
A Group 2
Experimental
Patients who have not taken ACE/ARB, randomized to take cozaar.
干预措施: start cozaar (Drug)
B
Experimental
Patients currently taking ACE/ARB will have their prescription changed to cozaar.
干预措施: continue cozaar (Drug)
结局指标
主要结局
AF burden
时间窗: 1 year
次要结局
未报告次要终点
研究者
研究点 (1)
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