RECRUITINGOBSERVATIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Locations (1)

Oslo University Hospital

Oslo, Norway