Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Echocardiofic changes of diastolic left ventricular function
研究概览
简要总结
Heart failure with normal ejection fraction is often under diagnosed and certainly under treated in hemodialyzed patients. Because of the benefit of reducing heart rate, ivabradine, a pure heart-rate lowering agent without effects on blood pressure, is of potential therapeutic utility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •hemodialyzed patients
- •signs and symptoms of heart failure with normal ejection fraction
- •sinus rhythm
排除标准
- •atrial fibrillation/atrial flutter
- •valvular heart disease
- •unstable angina
- •hospitalization for heart failure prior 3 months
研究组 & 干预措施
IVABRADINE, HEART FAILURE WITH NORMAL EF
Patient on hemodialysis with Heart failure with normal ejection fraction treated with ivabradine titrated to 7.5 mg BID to assess changes in echocardiography diastolic function and NYHA class and 6-minutes walking test
干预措施: Ivabradine (Drug)
结局指标
主要结局
Echocardiofic changes of diastolic left ventricular function
时间窗: baseline, 1, 3, 6, 9, 12 months
Measures of diastolic left ventricular function (E and A velocity and deceleration time of mitral inflow and Doppler-Tissue-Imaging E velocity and their ratio) were assessed at baseline and at each scheduled time.
次要结局
- changes in 6-minutes walking test(baseline, 1,3,6,9,12 months)
- changes in NYHA class(baseline, 1,3,6,9,12 months)