Clinical Trial

Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial

Recruiting
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Record status
This record was last updated August 22, 2025 (before its estimated April 2026 completion). Its status may not reflect the trial's current state.
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.
Trial Details
NCT Number NCT07137260
Lead Sponsor Simon Jäger
Collaborators: Klinikum Nürnberg, LMU Klinikum, SLK Kliniken Heilbronn GmbH, Robert Bosch Medical Center
Conditions Pulmonary Hypertension, Precapillary Pulmonary Hypertension, Right Heart Catheterisation, Digital Mobility Outcomes
Enrollment 77 participants
Start Date 2024-04-19
Primary Completion 2026-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2025-08-22