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โ† Trials
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Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis

Recruitingn/aAges 18 Years - anyAllOslo University Hospital
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In plain words

What the trial is, and whether it could suit you

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-t

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ค15 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
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What it tests

  • Not listed
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Where

1 site
Oslo University Hospital
Oslo, Norway
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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