Home-Based Clinical Management of Cardiac Complications in Systemic Sclerosis

NCT06865118 | Recruiting

• 1 other identifier: 762859
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Systemic Sclerosis; Pulmonary arterial hypertension; Home monitoring; Remote monitoring; Observational study; PAH progression; Disease progression; Home-based markers

Outcome Measures

Primary Outcomes (8)

• Feasibility of Home Monitoring: Patient Adherence and Compliance

  Adherence and compliance will be assessed by tracking the frequency and completeness of data entries in the digital platform. This includes biweekly symptom reporting, completion of the 1-minute sit-to-stand test (1MSTS), and compliance with ECG monitoring.

  From enrollment to the end of the study at 12 weeks

• Feasibility of Home Monitoring: Technical Feasibility

  Technical feasibility will be evaluated based on the occurrence of technical failures, data loss, and missing entries in the home monitoring system. The frequency of reported technical issues and the ability of participants to successfully complete monitoring tasks will be recorded.

  From enrollment to the end of the study at 12 weeks

• Feasibility of Home Monitoring: Agreement Between Home-Based 1MSTS and Hospital-Based 6MWD for Exercise Capacity Assessment

  Agreement between home-based 1-minute sit-to-stand test (1MSTS) and hospital-based 6-minute walk distance (6MWD) in assessing exercise capacity will be evaluated using correlation analysis (e.g., Pearson or Spearman correlation) and Bland-Altman plots to assess agreement. A regression model may be applied to explore the predictive relationship between 1MSTS (number of repetitions) and 6MWD (distance in meters). Unit of Measure: * Primary Unit: Agreement (correlation coefficient) * Secondary Units: 1MSTS (number of repetitions), 6MWD (meters)

  From enrollment to 12 weeks

• Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based Peripheral Oxygen Saturation (SpO₂) at Rest and Nadir During Exercise

  Agreement between home-based and hospital-based peripheral oxygen saturation (SpO₂) at rest and the lowest (nadir) value during the tests. Unit of Measure: Percentage (%)

  From enrollment to 12 weeks

• Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based Heart Rate Measurements at Rest, Peak Exercise, and Recovery

  Agreement between home-based and hospital-based heart rate measurements at rest, at maximum during the tests, and one minute after the tests. Unit of Measure: Beats per minute (bpm)

  From enrollment to 12 weeks

• Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based Borg Dyspnea Scale Scores During Exercise

  Agreement between home-based and hospital-based Borg dyspnea scale scores during the tests. Unit of Measure: Borg dyspnea scale score

  From enrollment to 12 weeks

• Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based Visual Analogue Scale (VAS) Scores for Dizziness and Palpitations

  Agreement between home-based and hospital-based Visual Analogue Scale (VAS) scores for dizziness and palpitations from 0 - 10 cm with higher values indicating more symptoms. Unit of Measure: VAS score (range: 0-10 cm)

  From enrollment to 12 weeks

• Feasibility of Home Monitoring: Agreement Between Home-Based and Hospital-Based NT-proBNP Measurements

  Agreement between home-based and hospital-based NT-proBNP measurements. Unit of Measure: pg/mL

  From enrollment to 12 weeks

Secondary Outcomes (24)

• Patient Satisfaction with Home Monitoring

  12 weeks

• Patient Usability, Feasibility and Impact of Home Monitoring

  12 weeks

• Patient Engagement with Healthcare Providers

  From enrollment to the end of the study at 12 weeks

• Impact of home monitoring on disease burden (EmPHasis-10 Score)

  Baseline and 12 weeks

• Impact of home monitoring on functional status (mMRC dyspnea scale)

  Baseline and 12 weeks

Study Arms (1)

SSc-PAH

This study includes adult patients diagnosed with systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH) who meet predefined eligibility criteria. All participants will undergo home monitoring using digital tools and attend two hospital visits for clinical assessments. The study aims to assess the feasibility, validity, and reliability of home-based monitoring in SSc-PAH patients. Participants will perform biweekly symptom reporting, functional tests, and blood sampling at home, in addition to comprehensive clinical evaluations at baseline and week 12. Home-based assessments will be compared to hospital-based assessments within the same participants to explore their agreement and potential clinical utility. The findings will inform the design of a future study on integrating home monitoring into routine clinical care.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will include adult patients diagnosed with systemic sclerosis-associated pulmonary arterial hypertension (SSc-PAH). Participants will be identified primarily through the Norwegian Systemic Connective Tissue Disease and Vasculitis Registry (NOSVAR) and routine in- and outpatient consultations. Additional recruitment will occur via the national rheumatic association, the OUH clinical studies webpage, and Helsenorge. Participants will attend two study visits at Oslo University Hospital (baseline and week 12). Given the rarity of SSc-PAH, broad recruitment is necessary to obtain feasibility data. The target enrollment is \~20 patients.

You may qualify if:

• 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

You may not qualify if:

• Severe end organ disease
• Severe heart failure with EF \< 30%
• End stage kidney disease with eGFR \< 30 mL/min
• End stage lung disease with FVC \< 50% or coexisting severe lung diseases (e.g., COPD (including emphysema), GOLD grade 3-4 with FEV1 \<50%)
• 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):
• Uncontrolled systemic hypertension (systolic \>220 mmHg or diastolic \>120 mmHg) or hypotension (systolic \<90 mmHg), resting tachycardia (\>130 beats per minute).
• Surgery, myocardial infarction/unstable angina, pneumothorax or stroke within the past 8 weeks.
• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

RECRUITING

Related Links

• Study information page on the Oslo University Hospital (OUH) website.

MeSH Terms

Conditions

Scleroderma, Systemic; Pulmonary Arterial Hypertension; Disease Progression

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anna-Maria Hoffmann-Vold, MD, PhD

  Oslo University Hospital

  STUDY CHAIR

Central Study Contacts

Hilde J Bjørkekjær, MD

CONTACT

0047 92884573; hjenss@sshf.no

Maylen N Carstens

CONTACT

004741305609; maylno@ous-hf.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr med

Study Record Dates

• First Submitted: February 17, 2025
• First Posted: March 7, 2025
• Study Start: March 16, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)