Home monitoring for cardiac issues in systemic sclerosis patients
The Nor-SSCardioCare Pilot Trial: Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis Patients
This study is testing if home monitoring can help people with systemic sclerosis-related lung high blood pressure keep track of their symptoms and health better than regular hospital visits.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 1 site (Oslo) |
| Trial ID | NCT06865118 on ClinicalTrials.gov |
What this trial studies
This observational pilot trial evaluates the feasibility of home monitoring for patients with systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH). Participants will use a digital platform for biweekly self-reporting of symptoms and physiological measurements, perform functional tests at home, and wear a heart monitoring device. The study aims to compare home-based assessments with traditional hospital assessments to detect disease progression and assess patient satisfaction and quality of life. The findings will inform the design of a larger trial to integrate home monitoring into clinical care.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with systemic sclerosis who also meet the criteria for pulmonary arterial hypertension.
Not a fit: Patients with severe end organ disease or those unable to use digital devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of disease progression and improved management of cardiac complications in systemic sclerosis patients.
How similar studies have performed: While home monitoring in chronic conditions is gaining traction, this specific approach for SSc-PAH is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oslo
- Oslo University Hospital — Oslo, Norway (Recruiting)
Study contacts
- Study coordinator: Hilde J Bjørkekjær, MD
- Email: hjenss@sshf.no
- Phone: 0047 92884573
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.