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RECRUITING
NCT07137260

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

Sponsor: Simon Jäger

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

77

Start Date

2024-04-19

Completion Date

2027-04

Last Updated

2025-08-22

Healthy Volunteers

No

Interventions

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.

Locations (4)

Robert Bosch Hospital

Stuttgart, Baden-Wurttemberg, Germany

Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic

Munich, Bavaria, Germany

Klinikum Nuremberg

Nuremberg, Bavaria, Germany

SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein

Löwenstein, Germany