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RECRUITINGOBSERVATIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form and to participate in the study procedures - Willingness to wear the Axivity AX6 Sensor for 7 days Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DEVICE

Accelerometer (measurement of walking activity)

Wearing an accelerometer (size 23x32,5x8,9 mm, weight 11g) on the lower back consistently for one week at a time to measure walking activity. The sensor is fixed with waterproof plasters. No feedback is given to the participant while wearing the sensor and no data can be read directly from the sensor.

Locations (4)

Robert Bosch Hospital
Stuttgart, Baden-Wurttemberg, Germany
Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic
Munich, Bavaria, Germany
Klinikum Nuremberg
Nuremberg, Bavaria, Germany
SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein
Löwenstein, Germany