跳至主要内容
临床试验/CTRI/2020/06/025735
CTRI/2020/06/025735尚未招募不适用

Perfenidone in Endomyocardial Fibrosis patients

Rohit Walia1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2020年6月30日最近更新:

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

发起方
Rohit Walia
申办方类型
Other [self]

研究点 (1)

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