Home Monitoring of Heart and Lung Complications in Systemic Sclerosis
Tests home monitoring for pulmonary arterial hypertension in adults with systemic sclerosis.
Plain-language title generated from the registry record
Registry title: Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis
Key facts
- Where
- Oslo, NorwaySee the site
Where in Norway
- Oslo University HospitalOslo, NorwayTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Oslo University Hospital
- Trial code
- NCT06865118
- Record updated
- 19 March 2025
- Original description
The goal of this observational pilot trial is to evaluate the feasibility of home monitoring for patients with systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH). The study will assess home-based measures that may help detect disease progression earlier and will also evaluate patient satisfaction, usability, and the impact on health-related quality of life.Read full original descriptionShow less
The Nor-SSCardioCare Pilot Trial: Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis Patients
The goal of this observational pilot trial is to evaluate the feasibility of home monitoring for patients with systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH). The study will assess home-based measures that may help detect disease progression earlier and will also evaluate patient satisfaction, usability, and the impact on health-related quality of life.
The study aims to answer:
* How feasible is home monitoring in SSc-PAH patients in terms of adherence, technical feasibility, and validity of home-based measures? * How do home-based assessments compare to hospital-based assessments in detecting disease progression? * How do patients experience digital home monitoring?
Participants will:
* Use a digital platform (Zeen Health) for biweekly self-reporting of symptoms and physiological measurements. * Perform functional tests at home, including the 1-minute sit-to-stand test (1MSTS). * Wear the ECG247 Smart Heart Sensor for one week to monitor heart rhythm. * Collect and submit home blood samples every two weeks. * Attend two hospital visits (baseline and week 12) for clinical assessments, functional testing, pulmonary function tests, echocardiography, and routine blood sampling for clinical assessments.
This 12-week study will assess the feasibility of home monitoring, as well as the validity and reliability of home-based measures. The findings will help design a future study aimed at integrating home-based assessments into routine clinical care.
Inclusion: 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: Active treatment for cancer or non-curable cancer; Contraindications for functional assessment (6MWD and 1MSTS):; Uncontrolled systemic hypertension (systolic >220 mmHg or diastolic >120 mmHg) or hypotension (systolic <90 mmHg), resting tachycardia (>130 beats per minute); Surgery, myocardial infarction/unstable angina, pneumothorax or stroke within the past 8 weeks; Severe musculoskeletal or neurological limitations preventing safe ambulation or any acute illness which might impair performance or safety in the opinion of the investigator; Severe end organ disease; Severe heart failure with EF < 30%; End stage kidney disease with eGFR < 30 mL/min; End stage lung disease with FVC < 50% or coexisting severe lung diseases (e.g., COPD (including emphysema), GOLD grade 3-4 with FEV1 <50%); In the opinion of the investigator, other clinically significant pulmonary abnormalities; Unable to speak, write and read Norwegian; Pregnancy or planned pregnancy.