Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
Recruiting · NCT07137260 · Observational (researchers observe without assigning treatment) · Lead sponsor: Simon Jäger
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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
Where it is running
4 locations listed.
- SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein - Löwenstein, Germany
- Robert Bosch Hospital - Stuttgart, Baden-Wurttemberg, Germany
- Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic - Munich, Bavaria, Germany
- Klinikum Nuremberg - Nuremberg, Bavaria, Germany