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.
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
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
Simon Jäger
Lead sponsor
Paracelsus Medical University
Sponsor institution
Klinikum Nürnberg
Collaborator
LMU Klinikum
Collaborator
SLK Kliniken Heilbronn GmbH
Collaborator
Robert Bosch Medical Center
Collaborator