NCT01255475已完成2 期
Effect of Blood Pressure Reduction in Patients With Chronic Heart Failure - Randomized, Double-blind, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Any cause mortality
研究概览
简要总结
Previous studies have demonstrated a direct association between blood pressure level and cardiovascular risk. However in patients with heart failure this association is considered controversial. The aim of this study is to evaluate the effect of the reduction of blood pressure in patients with heart failure. The investigators will examine the effects of this intervention over mortality, quality of life, and cardiac function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •stable chronic heart failure for at least 6 months
- •ejection fraction of 40% or less, as measured by transthoracic echocardiography
- •optimal clinical treatment for chronic heart failure according to current international guidelines.
排除标准
- •patient refusal
- •rheumatic or degenerative valvular disease
- •restrictive cardiomyopathy
- •evidence of myocardial ischemia
- •alcohol or drug use
- •malignant neoplasm
- •active infection
- •surgical intervention in the 3 previous months
- •lactation, childbearing or childbearing potential.
- •pulmonary embolism in the 6 previous months
研究组 & 干预措施
Intervention
Experimental
干预措施: Hydralazine/amlodipine (Drug)
Control
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Any cause mortality
时间窗: 12 months after randomization
Unplanned hospital admission from any cause
时间窗: 12 months after randomization
次要结局
- Cardiovascular death(12 months after randomization)
- Acute myocardial ischemia(12 months after randomization)
- Stroke(12 months after randomization)
- Symptomatic hypotension(12 months after randomization)
- Renal function(12 months after randomization)
- Peak exercise oxygen consumption(12 months after randomization)
- Quality of life(12 months after randomization)
研究者
Edimar Alcides Bocchi
Heart Failure Team Directos
University of Sao Paulo
研究点 (1)
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