Trials / Recruiting
RecruitingNCT07137260
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 77 (estimated)
- Sponsor
- Simon Jäger · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Pulmonary Hypertension
- Precapillary Pulmonary Hypertension
- Right Heart Catheterisation
- Digital Mobility Outcomes
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Accelerometer (measurement of walking activity) | Wearing an accelerometer (size 23x32,5x8,9 mm, weight 11g) on the lower back consistently for one week at a time to measure walking activity. The sensor is fixed with waterproof plasters. No feedback is given to the participant while wearing the sensor and no data can be read directly from the sensor. |
Timeline
- Start date
- 2024-04-19
- Primary completion
- 2026-04-01
- Completion
- 2027-04-01
- First posted
- 2025-08-22
- Last updated
- 2025-08-22
Locations
4 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT07137260. Inclusion in this directory is not an endorsement.