Actively Recruiting
Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis
Led by Oslo University Hospital · Updated on 2025-03-19
20
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fulfilment of the 2013 American College of Rheumatology/European Alliance of Associations for Rheumatology (ACR/EULAR) systemic sclerosis classification criteria
- Fulfilment of the 2022 hemodynamic definition of pulmonary arterial hypertension (mean pulmonary arterial pressure >20 mmHg, pulmonary artery wedge pressure ≤15 mmHg, and pulmonary vascular resistance >2 WU) without other causes of pre-capillary pulmonary hypertension
- Ability to understand and follow trial procedures including completing patient-reported outcome questionnaires
- Access to the internet and experience using smartphones or other internet-enabled electronic devices
- Capability to provide signed informed consent
You will not qualify if you...
- Severe end organ disease including:
- Severe heart failure with ejection fraction <30%
- End stage kidney disease with eGFR <30 mL/min
- End stage lung disease with forced vital capacity <50% or severe lung diseases such as COPD GOLD grade 3-4 with FEV1 <50%
- Other clinically significant pulmonary abnormalities as judged by the investigator
- Active or non-curable cancer
- Contraindications for functional assessments including:
- Uncontrolled systemic hypertension (systolic >220 mmHg or diastolic >120 mmHg) or hypotension (systolic <90 mmHg), or resting tachycardia (>130 bpm)
- Surgery, myocardial infarction, unstable angina, pneumothorax, or stroke within the past 8 weeks
- Severe musculoskeletal or neurological limitations preventing safe walking or any acute illness impairing test performance or safety
- Inability to speak, write, and read Norwegian
- Pregnancy or planned pregnancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Oslo University Hospital
Oslo, Norway
Actively Recruiting
Research Team
H
Hilde J Bjørkekjær, MD
CONTACT
M
Maylen N Carstens
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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