NCT02441218已完成3 期
Effects of Ivabradine on Cardiovascular Events in Patients With Moderate to Severe Chronic Heart Failure and Left Ventricular Systolic Dysfunction. A Three-year International Multicentre Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 6,505
- 试验地点
- 2
- 主要终点
- Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.
研究概览
简要总结
The primary objective of this study is to demonstrate the superiority of ivabradine over placebo in the reduction of cardiovascular mortality or hospitalisation for worsening heart failure in patients with moderate to severe symptoms of chronic heart failure, a reduced left ventricular ejection fraction and currently receiving recommended therapy for this disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Symptomatic Chronic heart failure (NYHA II, III or IV)
- •Left ventricular systolic dysfunction (LVEF ≤ 35%)
- •Sinus rhythm and resting heart rate ≥ 70 bpm
- •Optimal and unchanged CHF medications or dosages
排除标准
- •Unstable condition within previous 4 weeks
- •Myocardial infarction or coronary revascularisation within previous 2 months
- •Stroke or transient cerebral ischaemia within previous 4 weeks
- •Congenital heart disease
- •Severe valvular disease
- •Active myocarditis
- •Permanent atrial fibrillation or flutter
研究组 & 干预措施
Ivabradine
Experimental
干预措施: Ivabradine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Primary Composite Endpoint: First Event Among Cardiovascular Death (Including Death of Unknown Cause) or Hospitalization for Worsening Heart Failure.
时间窗: All over the study (up to 42 months).
Number of patients having experienced the Primary Composite Endpoint.
次要结局
- Unplanned Hospitalisation for CV Reason(From the date of randomisation to the first documented hospitalisation, up to 42 months.)
- Cardiovascular Death(From the date of randomization until the date of death, up to 42 months)
- Hospitalisation for Worsening Heart Failure(From the date of randomization to the date of first documented hospitalisation, up to 42 months)
- All-cause Mortality(From the date of randomisation to death, up to 42 months.)
- Death From Heart Failure(From the date of randomisation to death, up to 42 months.)
- Hospitalisation for Any Cause(From the date of randomisation to the date of first documented hospitalisation, up to 42 months)
- Hospitalisation for Cardiovascular Reason(From the date of randomisation to the first documented hospitalisation, up to 42 months)
- Unplanned Hospitalisation for Any Cause(From the date of randomisation to the first documented hospitalisation, up to 42 months)
- Secondary Composite Endpoint(From the date of randomisation to the date of the first event, up to 42 months)
研究者
研究点 (2)
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Effect of ivabradine versus placebo on cardiac function and on capacity to perform exercise in patients suffering from diastolic heart failure.Heart failure with preserved left ventricular ejection fractionMedDRA version: 17.0Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849EUCTR2012-002742-20-ATInstitut de Recherches Internationales Servier400
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Effect of ivabradine versus placebo on cardiac function and on capacity to perform exercise in patients suffering from diastolic heart failure.Heart failure with preserved left ventricular ejection fractionMedDRA version: 15.1Level: LLTClassification code 10008908Term: Chronic heart failureSystem Organ Class: 100000004849EUCTR2012-002742-20-ITInstitut de Recherches Internationales Servier400