Wearable sensor tracking of walking in adults with precapillary pulmonary hypertension

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter observational effort enrolling adults with precapillary pulmonary hypertension confirmed by right heart catheterization. Participants wear an Axivity AX6 sensor on the lower back for one week at baseline and again at two scheduled follow-ups (around 3–6 months and 6–12 months) while clinical care continues per their physician. The main goal is to see whether digital mobility outcomes derived from accelerometer data correlate with invasive measures of pulmonary arterial pressure and resistance obtained by right heart catheterization. Data are collected at academic hospitals in Stuttgart, Munich, and Nuremberg, and participants can opt to receive feedback about their sensor measurements.

Why it matters

Who can join: the full rules

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's running

• Robert Bosch Hospital
  Stuttgart, Baden-Wurttemberg, Germany Recruiting
• Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic
  Munich, Bavaria, Germany Recruiting
• Klinikum Nuremberg
  Nuremberg, Bavaria, Germany Recruiting
• SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein
  Löwenstein, Germany Not yet recruiting

Study contacts

• Study coordinator: Prof. Dr. med. Simon Jäger
• Email: simon.jaeger@klinikum-nuernberg.de
• Phone: +49 911-398-2822

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.