NCT07137260Recruiting
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
Source: ClinicalTrials.gov · Last updated 22 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to validate digital mobility outcomes for monitoring the treatment and disease progression in adult patients with pulmonary hypertension. The main question it aims to answer is: -Do digital mobility outcomes (measured digital endpoints characterizing walking behavior) correlate with measures of precapillary pulmonary pressure as assessed by right heart catheterization? Participants will be asked to wear a small sensor on the lower back for one week at a time for a total of 3 times: at diagnosis and follow-up visits at 3-6 months and again at 6-12 months. Follow-up visits are scheduled by the treating clinician. At the end of the study participants can choose to receive feedback on the sensor measurements.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 77 (estimated)
- First submitted
- 9 Jul 2025
- Start date
- 19 Apr 2024
- Primary completion date
- Apr 2026
- Lead sponsor
- Simon Jäger
- NCT number
- NCT07137260
What you commit to
- Study type: Observational
- Planned participants: 77
- From 19 Apr 2024 to the primary completion date, Apr 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Hospitalization for a pulmonological disease within the 30 days prior to study recruitment
Other illness
- Neurological or orthopedic disease which limits walking ability
- Terminal illness with life expectancy \< 1 year
- Ongoing treatment for malignancy
- Acute psychosis or other severe psychiatric illness
Other
- Acute pain which limits walking ability
- Poor vision, which limits walking ability
- Substance dependence
Who the study is looking for
- Pulmonary hypertension confirmed by right heart catheterization
- Presence of precapillary pulmonary hypertension at time of recruitment, defined as mean pulmonary arterial pressure (MAP) ≥ 20 mmHg, pulmonary arterial wedge pressure (PAWP) ≤ 15 mmHg and pulmonary vascular resistance (PVR) \> 2 Wood units (160 dyn·s·cm-5)
- After the right heart catheterization another follow-up visit is required in 3, 6, or 12 months
- Independent walking without assistance and a 6-min walking distance \> 100m
- WHO Functional Class I-III
- Ability to provide informed consent and to participate in the study procedures
- Willingness to wear the Axivity AX6 Sensor for 7 days
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein Coordinator of this site? Confirm its status | Löwenstein | Germany | Not yet recruiting |
| Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic Coordinator of this site? Confirm its status | Munich | Germany | Recruiting |
| Klinikum Nuremberg Coordinator of this site? Confirm its status | Nuremberg | Germany | Recruiting |
| Robert-Bosch-Hospital Coordinator of this site? Confirm its status | Stuttgart | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.