NCT00343902已完成3 期
Randomized Clinical Trial of a Crataegus Oxycantha Extract in Chronic Heart Failure
National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2000年1月最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Distance walked on a six minute walk test at six months
研究概览
简要总结
To determine the effect of hawthorn extract 450 mg bid vs. placebo, in addition to standard medical therapy in ambulatory patients with NYHA class II to IV chronic heart failure on submaximal exercise as measured by the 6-minute walk test
详细描述
See Brief Summary
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
- Double
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
- •Ambulatory individuals 18 years and older who had been diagnosed with CHF (NYHA functional classes II-IV) for > 3 months
- •Left ventricular ejection fraction (LVEF) of ≤ 40 percent
- •Receiving indicated standard therapy (if not contraindicated or intolerant for > 3 months) defined as a diuretic, an ACE-inhibitor or an angiotensin receptor blocker (ARB) and a beta-blocke
- •Patients with NYHA class III or IV symptoms were also required to receive spironolactone. Doses of these drugs had to be stable for ≥ 3 months, except for diuretics, for which ≥ 1 month of stability was required.
排除标准
- •Hemodynamically severe uncorrected primary valvular disease
- •Active myocarditis
- •Hypertrophic cardiomyopathy
- •Restrictive cardiomyopathy
- •Myocardial infarction, stroke, unstable angina, coronary artery bypass graft surgery, valvular surgery, or angioplasty < 3 months before randomization
- •Symptomatic or sustained ventricular tachycardia not controlled by antiarrhythmic drugs or an implantable cardioverter-defibrillator
- •Any condition other than heart failure that would be expected to limit exercise (e.g., angina, peripheral vascular disease, pulmonary disease, arthritis, or an orthopedic problem severe enough to limit exercise)
- •Nursing mothers, pregnant women and those planning a pregnancy during the study period
结局指标
主要结局
Distance walked on a six minute walk test at six months
次要结局
- Minnesota Living with Hearth Failure Questionnaire (Disease specific quality of life)
研究者
研究点 (2)
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