CTRI/2020/06/025735尚未招募不适用
Perfenidone in Endomyocardial Fibrosis patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Rohit Walia
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- change in myocardial extracellular volume
研究概览
简要总结
Endomyocardial Fibroisis is a disease with no curative treatment or drug to limit fibrosis progression . Perfenidone is an anti fibrotic drug which is approved for treatment of idiopathic pulmonary fibrosis which is also characterised by diffuse severe fibrosis of lungs. Perfenidone has shown good results in randomised controlled trails for this condition . We plan to test perfenidone for end-myocardial fibrosis patients and use cardiac MRI to evaluate its effect on the progression of disease over one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Endomyocardial Fibrosis patients Informed consent.
排除标准
- •Chronic Renal Failure Liver Failure Expected life expectancy less than one year Associated Malignancy Assisted circulation Cardiac devices Contraindications to MRI.
结局指标
主要结局
change in myocardial extracellular volume
时间窗: 1 year
次要结局
- Absolute change in LV and RV mass, volume, ejection fraction, myocardial cell volume, LV diastolic function, strain, backscatter and backscatter and torsion(Absolute change in left atrium and right atrium volume and function and left atrial function , Absolute change in NT pro BNP and HS- Troponin T ,Absolute change in exercise tolerance)
研究者
研究点 (1)
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