跳至主要内容
临床试验/CTRI/2020/01/022990
CTRI/2020/01/022990已完成不适用

Exosomes in pulmonary arterial hypertension with and without the exposure to exercise

ICMR1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2020年1月30日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
36
试验地点
1
主要终点
Circulatory metabolites

研究概览

简要总结

Pulmonary arterial hypertension (PAH) is a chronic disease with severe morbidity and mortality. The role of exosomes (EXO) contributing to PAH is now being explored with two studies showing benefits. Exercise is a promising intervention that produces functional and clinical benefits in PAH. Nevertheless, the role of EXO and exercise in PAH has yet to be explored. This study thus aims to study the effects of exercise on changes in the EXO in an animal model of PAH and human participants with PAH

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients who are diagnosed with Pulmonary Hypertension (PH) of Group 1 (acc.
  • to WHO classification) and any functional class, stable on medical therapy for 2 months and having a tricuspid regurgitation velocity ≥3.4m/s with or without right ventricular dysfunction, detected on transthoracic echocardiography For the purpose of metabolomics, a discovery group comprising of 10 healthy age matched controls, free of co-morbidities shall be recruited.

排除标准

  • patients with neuromuscular complications limiting cardiac rehabilitation, acute coronary events, uncontrolled arrhythmias, patients on long term oxygen therapy.

结局指标

主要结局

Circulatory metabolites

时间窗: At baseline | 3 months follow up | 6 months follow up

次要结局

  • 6Minute Walk Test, Short Physical Performance Battery, clinical frailty score, cardiac self-efficacy, quality of life, cardiac depression scale, muscle strength, cardiac function(at baseline, 3 months follow up and 6 months follow up)

研究者

发起方
ICMR
申办方类型
Government funding agency

研究点 (1)

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