Home monitoring for cardiac issues in systemic sclerosis patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Oslo University Hospital
  Oslo, Norway Recruiting

Study contacts

• Study coordinator: Hilde J Bjørkekjær, MD
• Email: hjenss@sshf.no
• Phone: 0047 92884573

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Treprostinil inhalation powder for PAH patients switching from selexipag

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.