Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis

Recruiting now

Conditions studied: Systemic Sclerosis (SSc), Pulmonary Arterial Hypertension (PAH), Home Monitoring Follow-up

In brief

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.

Key facts

Study ID

NCT06865118

Run by

Oslo University Hospital

People needed

20

Starts

2025-03-16

Expected to finish

2025-07-01

Last updated by the study team

2025-03-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• 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.
• Unable to speak, write and read Norwegian
• Pregnancy or planned pregnancy

Where it is running

• Oslo University Hospital — Oslo, Norway (enrolling)

Full record on ClinicalTrials.gov

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