Cardioselective Beta-Blockade Using Bisoprolol in Patients With Chronic Heart Failure (CHF) and Coexistent Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) With or Without Significant Reversibility.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Forced expiratory volume 1 second (FEV1)
研究概览
简要总结
The principal research objectives are to demonstrate cardioselective beta-blockade using bisoprolol is not inferior to placebo with regard to pulmonary function and improves quality of life in patients with heart failure and coexistent moderate or severe chronic obstructive pulmonary disease with or without significant reversibility. Patients will be followed up for 4 months during which bisoprolol will be up-titrated to the maximum clinically tolerated dose. Health status will be assessed using a generic and two disease specific questionnaires, and pulmonary function by spirometry, body box plethysmography, and cardiopulmonary exercise testing.
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, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic NYHA II or III chronic heart failure
- •left ventricular systolic dysfunction
- •moderate or severe chronic obstructive pulmonary disease
- •with or without significant reversibility
排除标准
- •beta-blocker contraindications
- •non-dihydropyridine (diltiazem / verapamil) calcium channel blockers
- •recent coronary percutaneous intervention or coronary artery bypass graft surgery
- •haemodynamically significant valvular disease or hypertrophic cardiomyopathy.
- •active myocarditis or pericarditis.
- •recent cerebrovascular accident or transient ischaemic attack
- •serious concurrent systemic disease, such as malignancy, resulting in likely reduced life expectancy
- •pregnancy, childbearing potential with inadequate contraception, breast feeding
研究组 & 干预措施
1
Bisoprolol
干预措施: Bisoprolol (Drug)
2
Identical appearance matching placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Forced expiratory volume 1 second (FEV1)
时间窗: 16 weeks
次要结局
- Quality of life: Minnesota Living with Heart Failure, SF-36(16 weeks)
- NYHA Class(16 weeks)