Comparing the Effects of Digoxin and Ivabradine on Mortality and Morbidity in Chronic Heart Failure With Reduced Ejection Fraction and Sinus Rhythm
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Cardiac function and functional status and biochemical parameters
研究概览
简要总结
Study hypothesis: Comparing the effect of digoxin and ivabradine in chronic heart failure patients with a left ventricular ejection of 35% or lower and sinus rhythm with heart rate 70 beats per minute or higher, and who are taking maximal dose of a beta blocker if tolerated.
详细描述
Selected patients have chronic heart failure with left ventricular systolic dysfunction and sinus rhythm. They take optimal medical therapy.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left ventricular ejection fraction of 35% or lower (Ischaemic or non-ischaemic etiology)
- •Sinus rhythm with heart rate of 70 beats per minute or higher
- •Symptomatic heart failure with functional capacity of New York Heart Association class II, III, IV
排除标准
- •Chronic renal failure with glomerular filtration rate <30 ml/min
- •Atrial fibrillation
- •Pace maker rhythm
- •Advanced stage chronic obstructive lung disease
- •Comorbidity with expected survival below 1 year
研究组 & 干预措施
Ivabradine
Ivabradine: initial dose of 5 mg b.id. dose up-titration to 7,5 mg b.id. in 2 weeks due to the heart rate and maintaining the last dose during 6 months.
干预措施: Ivabradine (Drug)
Digoxin
Digoxin: Digoxin 0,25 mg once a day 5 days per week during 6 months.
干预措施: Digoxin (Drug)
结局指标
主要结局
Cardiac function and functional status and biochemical parameters
时间窗: After 6 months
Cardiac function (echocardiography): Systolic function (left ventricular ejection fraction) and diastolic function (Doppler E/A ratio, tissue Doppler e/e1 ratio, Doppler deceleration time of the E wave, left atrium volume index) Maximal oxygen consumption will be evaluated with cardiopulmonary exercise testing Changes in proBNP level (serum value) after treatment
次要结局
- Cardiovascular mortality(Up to 6 months)
- All cause mortality(Up to 6 months)
- Hospital admission for worsening heart failure(Up to 6 months)
- Heart rate and blood pressure(After 6 months)
研究者
Kurtulus Karauzum
Kurtulus Karauzum
Kocaeli University