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| Name | Class |
|---|---|
| Klinikum Nürnberg | OTHER |
| LMU Klinikum | OTHER |
| SLK Kliniken Heilbronn GmbH | OTHER |
| Robert Bosch Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients newly diagnosed with precapillary pulmonary hypertension | Diagnosis of precapillary pulmonary hypertension confirmed by right heart catheterization (as described under inclusion criteria) with follow-up visits planned by the treating clinician in the next 3-12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerometer (measurement of walking activity) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with precapillary pulmonary hypertension and receiving treatment at participating study centres.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. med. Simon Jäger | Contact | +49 911-398-2822 | simon.jaeger@klinikum-nuernberg.de | |
| Simone Panzer | Contact | +49 911-398-119943 | simone.panzer@klinikum-nuernberg.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert Bosch Hospital | Recruiting | Stuttgart | Baden-Wurttemberg | 70376 | Germany |
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| OTHER |
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|
| 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. | 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). |
| 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. | 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 important prognostic markers of cardiac function | Correlation of validated digital mobility outcomes with prognostic markers of cardiac function:
| 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 digital mobility outcomes and disease progression | 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. | 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). |
| Investigation of potential confounders | 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. | From enrollment to end of study after the last follow-up visit at 6-12 months. |
| Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic | Recruiting | Munich | Bavaria | 81377 | Germany |
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| Klinikum Nuremberg | Recruiting | Nuremberg | Bavaria | 90419 | Germany |
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| SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein | Not yet recruiting | Löwenstein | 74245 | Germany |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D000081029 | Pulmonary Arterial Hypertension |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
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