Effect of Ivabradine, Carvedilol or Their Combination in Patients With Heart Failure
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 2
- 主要终点
- Exercise Tolerance Assessed by 6 Minute Walking Test
研究概览
简要总结
Patients with heart failure (HF) have a limited exercise tolerance,few pharmacological interventions have been proven effective in improving exercise capacity. At the presence there i conflicting evidence on the effectiveness of beta-blockers on exercise capacity. Ivabradine has been shown to improve prognosis in patients with ischemic heart disease, left ventricular dysfunction and heart rate > 70 bpm. The association of ivabradine and atenolol has been proven effective in increasing exercise tolerance in patients with ischemic heart disease. Aim of the present study is to evaluate the effect of heart rate reduction with ivabradine, carvedilol or their combination in patients with heart failure of ischemic origin.
详细描述
Patients with chronic heart failure of ischemic origin (120) Stable coronary artery disease Acute coronary syndromes > 3 months Revascularization procedures > 3 months Naive on heart rate reducing agents New York Heart Association (NYHA) Class II III 6 minute walking test (6MW) tolerance between 200 and 400 m Stable medications for the past 3 months
Treatment Ivabradine up to 7.5 mg b.i.d. Carvedilol up to 25 mg b.i.d. Carvedilol and Ivabradine up to 12.5/5 mg b.i.d.
Efficacy measure Intention to treat Exercise tolerance Quality of life
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 (Participant, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heart failure II-III
- •ischemic origin
- •stable medications from at least 3 months
- •> 3 months from an acute ischemic syndrome or revascularization procedure
- •naive on heart rate reducing agents
排除标准
- •bradycardia
- •hypersensitivity or contraindications to study drugs
- •exercise tolerance at 6 minute walking test <100 m or >400 m
研究组 & 干预措施
Ivabradine
7.5 mg bd
干预措施: ivabradine (Drug)
Carvedilol
up to 25 mg bd
干预措施: Carvedilol (Drug)
结局指标
主要结局
Exercise Tolerance Assessed by 6 Minute Walking Test
时间窗: 3 months
Distance measured at 6 minute walking test. The 6 minute walking test was performed according to standardised procedure at baseline, before inclusion (at least 1 week after baseline evaluation), and at the end of the study. Patients who had not done at least two tests in the past underwent two practice 6 minute walking tests at least 3 days apart. Results are expressed in terms of distance walked (metres). The test was supervised by a physical therapist. Patients were asked to walk at their own maximal pace a 100 m long hospital corridor. At the beginning of the last (6th) minute of the test a standard phrase of encouragement was told. Patients were allowed to stop if signs or symptoms of significant distress occurred (dyspnea, angina), through they were instructed to resume walking as soon as possible.
Maximal Oxygen Consumption
时间窗: 3 months
Functional capacity was assessed by means of a cardiopulmonary exercise test with a bicycle ergometer with gas exchange monitoring (Vmax 29 C, SensorMedics). Peak oxygen consumption was defined as the maximal oxygen consumption (MVO2) observed during exercise.
次要结局
- Quality of Life(3 months)
- New York Heart Association (NYHA) Class(3 months)
研究者
Giuseppe M.C. Rosano
Principal investigato
IRCCS San Raffaele