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

Recruitingn/aAges 18 Years - anyAllSimon Jäger
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Accelerometer (measurement of walking activity)
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Where

4 sites
Robert Bosch Hospital
Stuttgart, Germany
Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic
Munich, Germany
Klinikum Nuremberg
Nuremberg, Germany
SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein
Löwenstein, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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