Efficacy of statins to reduce the incidence of pacemaker induced cardiomyopathy – An open label randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Development of pacemaker induced cardiomyopathy
研究概览
简要总结
The primary purpose of this protocol is to assess the effectiveness of statins in decreasing the incidence of pacemaker-induced cardiomyopathy (PICMP) among patients receiving permanent pacemakers. Right ventricular pacing can lead to left ventricular dysfunction over time, resulting in PICMP, with an incidence reported between 5% to 30% of cases. This study hypothesizes that daily administration of 40 mg of atorvastatin will mitigate PICMP incidence by stabilizing cardiac function over a 1-year period. Should the results prove favorable, this intervention could support the routine use of statins as a preventive measure in pacemaker patients, ultimately aiming to improve their long-term cardiac outcomes and reduce progression to heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Underwent pacemaker implantation within three days 2.Anticipated ventricular pacing requirement more than 40%.
排除标准
- •1.Patients with LVEF < 50% 2.Patients who are already on statins or have an indication for statins.
结局指标
主要结局
Development of pacemaker induced cardiomyopathy
时间窗: 1 year
次要结局
- Incidence of elevated NT-proBNP levels at six months in both the statin and control group(6 months)
研究者
Rohit Varma
Jawaharlal Institute of Postgraduate Medical Education and Research
