The Impact of Ivabradine Administration on Clinical Outcome and Biomarkers of Decompensated Heart Failure
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- serum Pro-BNP level
研究概览
简要总结
The aim of the work is to Evaluate the efficacy, quality of life and safety of early addition of ivabradine to B-blocker in reduced EF heart failure patients after acute decompensation compared to the standard treatment.
详细描述
this study is a Prospective randomized open label study will be conducted on Egyptian patient with heart failure with reduced ejection fraction(rEF HF). Each of the eligible patients will be randomized to one of these groups, early administration of Ivabradine and B-blocker group or control group which follows American Heart Association treatment guidelines of rEF HF.
The objectives include the following:
- Physical examination (heart rate, blood pressure, dyspnea and orthopnea symptoms)
- NYHA class
- Pro-NT-BNP serum level, ST2 serum level
- Echocardiography (left ventricular ejection fraction)
- Score of Minnesota Living with Heart Failure Questionnaire these objectives will be measured baseline, 2 weeks and after 3 months
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with acute heart failure either newly diagnosed or decompensated heart failure after stabilization
- •Patients > 18 years old
- •Left ventricular ejection fraction less than 40 % of presumed irreversible etiology
- •Clinically stable 24-48 hours after admission
- •Sinus rhythm with heart rate above 70 bpm
- •No previous treatment with ivabradine
排除标准
- •Patients less than 18 years.
- •Arterial fibrillation before inclusion.
- •Ventricular dysfunction due to acute event (Myocarditis, AMI). 4- cardiogenic shock
- •Patients are taking drug interact with ivabradine. 6- carrier or candidate for pacemaker, heart transportation, cardiac surgery or other cardiovascular procedure
研究组 & 干预措施
Ivabradine group
an initial dose of 5 mg/12 hours of Ivabradine will be added to beta-blockers (bisoprolol 2.5 mg/day) and ivabradine will be increased until a dose of 7.5 mg/12 hours according to HR. The heart rate target will be at least <70 bpm and not lower than 60 bpm. If HR decreases below 60 bpm, ivabradine and/or beta-blockers doses will be decreased to the previous dose. After discharge, beta-blockers up-titration will be continued during follow-up visit.
干预措施: Ivabradine (Drug)
Ivabradine group
an initial dose of 5 mg/12 hours of Ivabradine will be added to beta-blockers (bisoprolol 2.5 mg/day) and ivabradine will be increased until a dose of 7.5 mg/12 hours according to HR. The heart rate target will be at least <70 bpm and not lower than 60 bpm. If HR decreases below 60 bpm, ivabradine and/or beta-blockers doses will be decreased to the previous dose. After discharge, beta-blockers up-titration will be continued during follow-up visit.
干预措施: Bisoprolol (Drug)
Control group
beta-blocker (bisoprolol 2.5 mg/day) and it will be doubled every 2 weeks during the admission according to the stability of HR, blood pressure and tolerability of patients. Ivabradine will be only added after reaching bisoprolol optimal dose (10mg) or maximum tolerated dose and the HR is still above 70 bpm. If HR decreases below 60 bpm, ivabradine dose will be decreased.
干预措施: Ivabradine (Drug)
Control group
beta-blocker (bisoprolol 2.5 mg/day) and it will be doubled every 2 weeks during the admission according to the stability of HR, blood pressure and tolerability of patients. Ivabradine will be only added after reaching bisoprolol optimal dose (10mg) or maximum tolerated dose and the HR is still above 70 bpm. If HR decreases below 60 bpm, ivabradine dose will be decreased.
干预措施: Bisoprolol (Drug)
结局指标
主要结局
serum Pro-BNP level
时间窗: 3 months
Elevated NT-proBNP parallel HF disease severity and it is suggestive of worse clinical outcomes and mortality in HF
次要结局
- Heart rate(3 months)
- ST2 serum level(3 months)
- The effect on patient quality of life using Minnesota Living with Heart Failure Questionnaire(3 months of follow-up.)
- NYHA class assessment(3 months)
- Left ventricular ejection fraction assessment(3 months)
- Blood pressure(3 months)
研究者
Nouran Ahmed Aly
Teaching Assistant of Clinical Pharmacy department
Sadat City University