CTRI/2025/02/080038尚未招募不适用
An Observational, Parallel arm study to assess safety, clinical utilization and effectiveness of Bisoprolol or Metoprolol in stable coronary Artery Disease with reduced ejection fraction (CADBIS Study)
Torrent Pharmaceuticals Ltd.1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年2月17日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 1. Mean change in LVEF after 8 and 24 weeks of treatment.
研究概览
简要总结
This is a Prospective, parallel arm, observational clinical study to study the impact of Bisoprolol or Metoprolol in stable coronary Artery Disease with reduced ejection fraction.
Total 80 patients will be enrolled in this study.
Study drug: Bisoprolol 2.5 or 5 mg and Metoprolol 25 or 50 mg
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female patients 18 to 65 years.
- •An echocardiogram within six months prior inclusion which indicated an abnormally functioning or dilated left ventricle with (No angina, No NYHA class III or class IV).
- •Stable CAD cases confirmed with coronary angiography
- •Ejection fraction less than 40 percent with or without Atrial Fibrillation.
- •Known CAD cases with any comorbid risk factors.
- •Not on Beta Blockers therapy.
- •Patient willing to enroll for the study.
- •Patient on background medical therapy or no therapy.
排除标准
- •Hypersensitivity to Bisoprolol or Metoprolol.
- •Patients with mildly reduced or preserved ejection fraction.
- •(greater than 40 percent)
- •Having a baseline heart rate less than 60 per min (sinus bradycardia).
- •Cardiogenic shock.
- •Second or third degree AV block.
- •Sick sinus syndrome.
- •For women only currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- •Stroke during last 30 days before enrolment.
- •Thromboembolic complications or thrombosis within 14 days before enrollment.
- •Use of psychoactive drugs.
结局指标
主要结局
1. Mean change in LVEF after 8 and 24 weeks of treatment.
时间窗: At 8 weeks and 24 weeks
2. Change in Blood Pressure (SBP & DBP) at 8 and 24 weeks from baseline.
时间窗: At 8 weeks and 24 weeks
3. Mean change in Heart rate (HR) from baseline to 8 and 24 weeks follow-up.
时间窗: At 8 weeks and 24 weeks
次要结局
- Mean change in LV volume (End Diastolic Volume or Preload)(At 8 weeks and 24 weeks)
- Mean change in LDL-C, HDL-C and Triglycerides level after 8 and 24 weeks from baseline(At 8 weeks and 24 weeks)
- Mean change in comorbid risk factors (Dyslipidemia or HTN or T2DM)(At 8 weeks and 24 weeks)
- Proportion of participants with treatment emergent adverse event during observation period.(At 8 weeks and 24 weeks)
- Concomitant medicine prescribing trend for CAD(At 8 weeks and 24 weeks)
研究者
Dr Arun Kumar G
Medical Trust Hospital
研究点 (1)
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