RecruitingNCT06865118

Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis

The Nor-SSCardioCare Pilot Trial: Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis Patients


Sponsor

Oslo University Hospital

Enrollment

20 participants

Start Date

Mar 16, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a home-based monitoring and management program for people with scleroderma (a disease that hardens skin and organs) who have also developed a serious lung condition called pulmonary arterial hypertension (high blood pressure in the lungs). **You may be eligible if...** - You have been diagnosed with systemic sclerosis (scleroderma) - You have been diagnosed with pulmonary arterial hypertension (PAH) confirmed by heart catheterization - You are able to use remote monitoring devices at home **You may NOT be eligible if...** - You are pregnant - You have severe heart failure or another serious heart condition that requires urgent hospital care - You are unable or unwilling to use home monitoring technology Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Oslo University Hospital

Oslo, Norway

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NCT06865118


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