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

NCT07137260 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 77

Last updated 2025-08-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Klinikum Nürnberg

    collaborator OTHER

  • LMU Klinikum

    collaborator OTHER

  • SLK Kliniken Heilbronn GmbH

    collaborator OTHER

  • Robert Bosch Medical Center

    collaborator OTHER

  • Simon Jäger

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-19
Primary Completion
2026-04-30
Completion
2027-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07137260 on ClinicalTrials.gov