Pilot Study Evaluating Home Monitoring for Heart and Lung Health in Adults with Systemic Sclerosis-Related Pulmonary Arterial Hypertension Over 12 Weeks

What this Trial Is About

Researchers are evaluating the feasibility of home monitoring for patients with systemic sclerosis-associated pulmonary arterial hypertension SSc-PAH, a serious complication of systemic sclerosis with high mortality if diagnosed late. This observational pilot study aims to assess if home-based methods can detect disease progression earlier, while also measuring patient satisfaction, usability of digital tools, and the impact on health-related quality of life over a 12-week period. Participants will use a digital platform to report symptoms and physiological data every two weeks, perform the one-minute sit-to-stand test 1MSTS at home, wear a smart heart sensor for one week to monitor heart rhythm, and collect blood samples biweekly. Two hospital visits at baseline and week 12 will include clinical assessments, pulmonary function tests, echocardiography, and routine blood sampling. The study compares home-based assessments with hospital-based ones to evaluate their agreement and reliability. During the study, participants will provide data through digital questionnaires and physiological tests, while researchers will monitor adherence, technical issues, and validity of home measures. Outcomes include feasibility of home monitoring, patient satisfaction, health-related quality of life, and heart rhythm analysis. The results will help design a larger trial to integrate home monitoring into routine clinical care for earlier detection of PAH progression in SSc-PAH patients.

Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis