NCT Number: NCT07137260
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Robert Bosch Hospital, Stuttgart, Baden-Wurttemberg, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline assessment at first diagnosis, follow-up assessments after 3-6 months and again after 6-12 months (follow-up time frames are determined by the treating clinician).
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.
Time frame: Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).
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.
Time frame: Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).
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.
Time frame: Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).
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.
Time frame: Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).
Correlation of validated digital mobility outcomes with prognostic markers of cardiac function:
Time frame: Measured at diagnosis (baseline visit) and two follow-up visits (between 3-6 months and again after 6-12 months, as determined by the treating clinician).
Correlation between validated digital mobility outcomes and clinical progression of pulmonary hypertension. Disease progression is measured by mortality, hospital admission secondary to pulmonary hypertension, and changes in any of the following: WHO functional class, REVEAL score (Registry Risk Score for Pulmonary Arterial Hypertension), COMPERA score (Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension), dyspnea (mMMRC), emPHasis-10 score, 6-minute walking test.
Time frame: From enrollment to end of study after the last follow-up visit at 6-12 months.
Investigation of potential confounders such as functional capacity (6-minute walking test, WHO functional class), sex, age, mono-, dual-, or tripple therapy for pulmonary hypertension.
Contact information is provided by the study sponsor or research team.
Prof. Dr. med. Simon Jäger
CONTACT
Simone Panzer
CONTACT
Simon Jäger
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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