Status:
RECRUITING
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
Lead Sponsor:
Simon Jäger
Collaborating Sponsors:
Klinikum Nürnberg
LMU Klinikum
Conditions:
Pulmonary Hypertension
Precapillary Pulmonary Hypertension
Eligibility:
All Genders
18+ years
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Hospitalization for a pulmonological disease within the 30 days prior to study recruitment
- Neurological or orthopedic disease which limits walking ability
- Acute pain which limits walking ability
- Poor vision, which limits walking ability
- Terminal illness with life expectancy \< 1 year
- Ongoing treatment for malignancy
- Acute psychosis or other severe psychiatric illness
- Substance dependence
Key Trial Info
Start Date :
April 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT07137260
Start Date
April 19 2024
End Date
April 1 2027
Last Update
August 22 2025
Active Locations (4)
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1
Robert Bosch Hospital
Stuttgart, Baden-Wurttemberg, Germany, 70376
2
Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic
Munich, Bavaria, Germany, 81377
3
Klinikum Nuremberg
Nuremberg, Bavaria, Germany, 90419
4
SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein
Löwenstein, Germany, 74245