Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis

Launched by OSLO UNIVERSITY HOSPITAL · Mar 3, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring the use of home monitoring for patients with systemic sclerosis-related pulmonary arterial hypertension (SSc-PAH). The main goal is to see if tracking health from home can help detect any worsening of the condition earlier and to find out how patients feel about using this technology. Participants will use a digital platform to report their symptoms and health measurements every two weeks. They’ll also perform some simple tests at home and wear a heart monitor for a week. Throughout the study, they will visit the hospital twice for more thorough health assessments.

To join the study, participants need to have a confirmed diagnosis of systemic sclerosis and pulmonary arterial hypertension, be able to follow the trial's procedures, and have access to the internet. They should also be comfortable using smartphones or other devices. It's important to note that those with severe heart, kidney, or lung diseases, or other serious health issues, may not be eligible. The trial will last for 12 weeks, and its findings could help shape future research on incorporating home-based health assessments into regular care for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Fulfilment of the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) SSc classification criteria
• • Fulfilment of the 2022 hemodynamic definition of PAH (mean pulmonary arterial pressure (mPAP) \>20 mmHg, pulmonary artery wedge pressure (PAWP) ≤15 mmHg, and pulmonary vascular resistance (PVR) \>2 WU) in the absence of other causes of pre-capillary PH (no significant ILD and no clinical suspicion of pulmonary or left sided heart disease as the predominant cause of PH), independent of diagnostic period and previous treatment
• • Participants must be able to understand and follow trial procedures including completion of questionnaires regarding Patient Reported Outcome measures
• • Participants must have access to the internet, and experience in using smartphones or other electronic devices with internet access.
• • Capable of giving signed informed consent
• Exclusion Criteria:
• • Severe end organ disease
• • 1. Severe heart failure with EF \< 30%
• • 2. End stage kidney disease with eGFR \< 30 mL/min
• • 3. End stage lung disease with FVC \< 50% or coexisting severe lung diseases (e.g., COPD (including emphysema), GOLD grade 3-4 with FEV1 \<50%)
• • 4. In the opinion of the investigator, other clinically significant pulmonary abnormalities
• • Active treatment for cancer or non-curable cancer
• * Contraindications for functional assessment (6MWD and 1MSTS):
• • 1. Uncontrolled systemic hypertension (systolic \>220 mmHg or diastolic \>120 mmHg) or hypotension (systolic \<90 mmHg), resting tachycardia (\>130 beats per minute).
• • 2. Surgery, myocardial infarction/unstable angina, pneumothorax or stroke within the past 8 weeks.
• • 3. Severe musculoskeletal or neurological limitations preventing safe ambulation or any acute illness which might impair performance or safety in the opinion of the investigator.
• • Unable to speak, write and read Norwegian
• • Pregnancy or planned pregnancy