Diastolic Heart Failure Management by Nifedipine
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 226
- 试验地点
- 1
- 主要终点
- Heart failure clinical composite response endpoint
研究概览
简要总结
Patients with heart failure with preserved ejection fraction have a equally high risk for mortality and re-hospitalization as those with reduced ejection fraction. Effective management strategies are critically needed to be established for this type of heart failure. These patients have more hypertensive and ischemic etiology than those with reduced ejection fraction. The investigators hypothesis is that Ca channel blocker nifedipine can improve the heart failure clinical composite response endpoint compared with the conventional treatment in patients with heart failure with hypertension and/or coronary artery disease and preserved ejection fraction (>=50%) by echocardiography. This study is multi-center, prospective, randomized, open-label, and blinded-endpoint design.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 years and older
- •Heart failure with history of hypertension and/or coronary artery disease
- •LVEF > or = 50% on echocardiography
排除标准
- •Valvular heart diseases with significant regurgitation and/or stenosis
- •Hypertrophic cardiomyopathy, restrictive cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, and active myocarditis
- •Constrictive pericarditis
- •Cardiogenic shock
- •Planned coronary artery bypass grafting or percutaneous coronary intervention within 3 months
- •History of acute coronary syndrome or stroke within 3 months
- •Pregnancy or breastfeeding
- •Hypersensitivity or contraindication to nifedipine
- •Inability to obtain informed consent
- •Any conditions not suitable for the participation in this trial judged by the investigator
研究组 & 干预措施
Conventional therapy plus nifedipine
干预措施: Conventional therapy plus nifedipine (Drug)
Conventional therapy
干预措施: Conventional therapy (Drug)
结局指标
主要结局
Heart failure clinical composite response endpoint
时间窗: up to 53 months
次要结局
- Cardiovascular death(up to 53 months)
- Stroke(up to 53 months)
- Death(up to 53 months)
- Hospital admission(up to 53 months)
- Hospital admission for cardiovascular disease(up to 53 months)
- Hospital admission for acute myocardial infarction, angina, coronary artery bypass grafting and percutaneous coronary intervention(up to 53 months)
- Hospital admission for worsening heart failure(up to 53 months)