Exosomes in PAH with and without exposure to exercise

Completed

Conditions: Primary pulmonary hypertension,

Registration Number: CTRI/2020/01/022990

Lead Sponsor: ICMR

Brief Summary: 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 36

Inclusion Criteria

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 â‰¥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.

Exclusion Criteria

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Circulatory metabolites	At baseline \| 3 months follow up \| 6 months follow up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): MAHE
🇮🇳
Udupi, KARNATAKA, India
MAHE
🇮🇳Udupi, KARNATAKA, India
Dr Abraham Samuel Babu
Principal investigator
9742502838
abraham.babu@manipal.edu