A Post-Marketing, Prospective, Observational Program: Effect of Ivabradrine in Lowering Heart Rate and Quality of Life in Chronic Heart Failure Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 主要终点
- Mean difference of Heart Rate
研究概览
简要总结
Elevated Heart rate (HR) (≥ 70 bpm) is one of the contributing factors in increasing the burden of hospitalization among Heart Failure patient. Ivabradine is a novel, selective and specific in inhibiting a Funny current in sinoatrial node Node and approved as an alternative therapy for Chronic Heart Failure (CHF) patients. CHF patients when treated with Ivabradine reported 39%, and 30% reduction in mortality and hospitalization rate respectively. Patient were treated with Ivabradine 5mg twice daily to determine its effect in lowering Heart rate and the Quality of Life (QOL) in Chronic Heart Failure patients
详细描述
A prospective, post-marketing observational study was conducted in 50 chronic heart failure patients with age 30-70yrs of NYHA Class II and prescribed 5 mg Ivabradine twice daily. Heart rate was evaluated through ECG & quality of life was measured by a validated questionnaire EuroQol-5 Dimension 3 level version (EQ-5D-3L). Baseline demographic includes age, gender, height, weight, Body Mass Index, temperature, blood pressure and respiratory rate were recorded and patients were followed at week 4 and week 8. Safety and tolerability was assessed by adverse drug reaction (ADR) monitoring. Results were analyzed by statistical software SPSS version 20.0.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Known case of Chronic Heart Failure (New York Heart Association (NYHA) functional class II to III)
- •Clinically stability (at least for 4 weeks)
- •Resting heart rate of more than 70 beats/ min (bpm) as assessed from the 12-lead electrocardiogram.
排除标准
- •Hypersensitivity to the active substance or to any of the excipients
- •Resting heart rate below 70 beats per minute prior to treatment
- •Cardiogenic shock
- •Acute myocardial infarction
- •Severe hypotension (< 90/50 mmHg)
- •Severe hepatic insufficiency
- •Sick sinus syndrome
- •Sino-atrial block
- •Unstable or acute heart failure
- •Pacemaker dependent (heart rate imposed exclusively by the pacemaker)
- •Unstable angina
- •Atrioventricular Block of 3rd degree
- •The combination with a strong cytochrome P450 3A4 inhibitors such as azole antifungals (ketoconazole, itraconazole), macrolide antibiotics (clarithromycin, erythromycin, telithromycin), HIV protease inhibitors (nelfinavir, ritonavir) and nefazodone
- •The combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties.
- •Pregnancy, lactation and women of child-bearing potential not using appropriate contraceptive measures
结局指标
主要结局
Mean difference of Heart Rate
时间窗: at 4 week and 8 week
The primary end-point was the overall response rate of patients to Ivabradine in achieving HR \<70 Bpm
次要结局
- Percentage of problems reported in EQ-5D descriptive system(at 4 week and 8 week)
- Median score of EQ-5D visual analogue scale(at 4 week and 8 week)
研究者
Dr. Fawad Farooq
Assistant Professor, Consultant Cardiologist
National Institute of Cardiovascular Diseases, Pakistan