NCT06865118 Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis
| NCT ID | NCT06865118 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oslo University Hospital |
| Condition | Systemic Sclerosis (SSc) |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-16 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-03-16 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Anna-Maria Hoffmann-Vold, MD, PhD
STUDY CHAIR
Oslo University Hospital
Frequently Asked Questions
Who can join the NCT06865118 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Sclerosis (SSc). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06865118 currently recruiting?
Yes, NCT06865118 is actively recruiting participants. Contact the research team at hjenss@sshf.no for enrollment information.
Where is the NCT06865118 trial being conducted?
This trial is being conducted at Oslo, Norway.
Who is sponsoring the NCT06865118 clinical trial?
NCT06865118 is sponsored by Oslo University Hospital. The principal investigator is Anna-Maria Hoffmann-Vold, MD, PhD at Oslo University Hospital. The trial plans to enroll 20 participants.