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
Patients diagnosed with precapillary pulmonary hypertension and receiving treatment at participating study centres.
Cohort
Prospective
Accelerometer (measurement of walking activity)
DeviceWearing 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.
Correlation of digital mobility assessments with measured pulmonary arterial pressures
Correlation of the digital mobility and walking parameters measured by the Axivity AX6 sensor with the precapillary pulmonary artery pressure during right heart catheterization. As the digital mobility parameters for pulmonary hypertension are still largely unknown, the primary variable will be the average walking speed for walking episodes of \> 30 seconds and compared with the measured pulmonary vascular resistance. The sensor is worn for 1 week at a time for a total of three sets of measurements (determined by scheduled clinical follow-up visits). The goal is to determine the feasibility of digital parameters for risk stratification and measuring disease activity and response to treatment.
Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: amount of walking episodes
Amount of walking episodes as measured by the AX6 Axivity Sensor. The sensor is worn on the lower back for 1 week at a time at diagnosis and two follow-up visits.
Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: duration of walking episodes
Duration of walking episodes in seconds, hours and minutes as measured by the AX6 Axivity Sensor. The sensor is worn on the lower back for 1 week at a time at diagnosis and two follow-up visits.
Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: amount of steps
Amount of daily steps as measured by the AX6 Axivity Sensor. The sensor is worn on the lower back for 1 week at a time at diagnosis and two follow-up visits.
Correlation between validated digital mobility outcomes and important prognostic markers of cardiac function
Correlation of validated digital mobility outcomes with prognostic markers of cardiac function: * Right heart catheterization: middle pulmonary arterial pressure, right atrial pressure, cardiac index, mixed venous saturation * Echocardiography: right atrial size, systolic pulmonary artery pressure (SPAP), Tricuspid annular plane systolic excursion (TAPSE) * NT-proBNP
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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
