Comparison of Digoxin and Ivabradine in Heart Failure With Preserved Systolic Function.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Cardiac function (diastolic and systolic function)
研究概览
简要总结
This is an investigator-started study. The trial is coded as no. GC&PJ-Dig-Iva2009-2012.
The authors have no conflict of interest and there was no financial sponsoring The study was planned according to the Good Clinical Quality standards using an intention-to-treat analysis. The protocol was approved from the ethics committee. Selected patients gave their written informed consent. The family practitioners agreed and obtained the collected data and analysis. Analysis of collected data was performed by a single-blinded author (without knowledge of the used test drug and time of collection of data).
Study Hypothesis: Compare the effect of digoxin and ivabradine in chronic heart failure with permanent atrial fibrillation (ischemic etiology).
Multiple Time Frames: Primary Outcome is measured before and after each medical intervention.
Measurements at baseline and after 3 month of therapy (twice, with the 2 different drugs):
Measurements Severity of dyspnea. Digoxin serum concentration. ECG: Heart rate at rest and during 6-min walking test. Cardiac function (echocardiography): systolic function (ejection rate, left trial size,diastolic function.
Participants were followed (ambulatory observation) for at least 3 months
详细描述
Selected patients had chronic coronary artery disease which had been treated with percutaneous dilatation & stenting and/or aortocoronary bypass. The severity of myocardial ischemia had induced heart failure with diastolic dysfunction and preserved systolic function, and permanent AF.
1 Inclusion criteria:
Dyspnea class III NYHA.
Abnormal left ventricular relaxation with preserved (≥52%) ejection fraction (LVEF).
Patients either in sinus rhythm or with permanent atrial fibrillation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 78 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •No need to change concomitant pharmacological therapy in the following months, dyspnea class III NYHA, and abnormal left ventricular relaxation with preserved (≥52%) left ventricular ejection fraction (LVEF).
排除标准
- •Unstable myocardial ischemia, reduced systolic cardiac function (LVEF<52%), diabetes mellitus requiring insulin, moderate or severe renal or hepatic dysfunction, or technically insufficient echocardiography.
研究组 & 干预措施
Digoxin cross-over ivabradine
Digoxin 0,125 mg once a day 5 days per week during 3 months. Ivabradine, 7,5 mg b.id. during 3 months.
干预措施: Digoxin and ivabradine (Drug)
结局指标
主要结局
Cardiac function (diastolic and systolic function)
时间窗: After 12-14 weeks
Cardiac function (echocardiography): systolic function (i.e. LVEF) and diastolic function (Doppler E/A ratio, tissue Doppler e/e1 ratio, Doppler deceleration time of the E wave.
次要结局
- NB-proBNP value(After 12-14 weeks)
- ECG(After 12-14 weeks)
- 6-min walk test(After 12-14 weeks.)
- Laboratory(After 12-14 weeks)
- Heart rate and blood pressure.(After 12-14 weeks)
- Dyspnea.(After 12-14.weeks)
- Body weight(12-14. weeks)
- Left atrial size(After 12-14 weeks)
- Side-effects(After 12-14 weeks)
研究者
Cocco G., M.D.
M.D., FESC
Cocco, Giuseppe, M.D.