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Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis

NCT06865118 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2025-03-19

No results posted yet for this study

Summary

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.

Conditions

  • Systemic Sclerosis (SSc)
  • Pulmonary Arterial Hypertension (PAH)
  • Home Monitoring Follow-up

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Anna-Maria Hoffmann-Vold, MD, PhD · Oslo University Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-16
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06865118 on ClinicalTrials.gov