跳至主要内容
临床试验/CTRI/2024/11/076660
CTRI/2024/11/076660招募中不适用

Efficacy of statins to reduce the incidence of pacemaker induced cardiomyopathy – An open label randomized controlled trial

Jawaharlal Institute of Postgraduate Medical Education and Research1 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2024年11月22日最近更新:

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

申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Rohit Varma

Jawaharlal Institute of Postgraduate Medical Education and Research

研究点 (1)

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