Pulmonary HypertensionNCT07137260
Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
An observational study of Pulmonary Hypertension and Precapillary Pulmonary Hypertension, run by Simon Jäger at 4 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension, Precapillary Pulmonary Hypertension, Right Heart Catheterisation
- What is being tested?
- Accelerometer (measurement of walking activity)
- Type of treatment
- Medical device
- How many people
- 77 participants
- Where
- 4 sitesGermany
- Study dates
- 19 Apr 2024to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with precapillary pulmonary hypertension and receiving treatment at participating study centres.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites, 4 recruiting
- Not yet recruiting
SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein
Löwenstein, 74245
Dr. med. Stephan Beckmann, stephan.beckmann@slk-kliniken.de
- Recruiting
Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic
Munich, Bavaria, 81377
Dr. med. Michaela Barnikel, michaela.barnikel@med.uni-muenchen.de
- Recruiting
Klinikum Nuremberg
Nuremberg, Bavaria, 90419
Prof. Dr. med. Simon Jäger, +49 911-398-2822, simon.jaeger@klinikum-nuernberg.de
Simone Panzer, simone.panzer@klinikum-nuernberg.de
- Recruiting
Robert Bosch Hospital
Stuttgart, Baden-Wurttemberg, 70376
Dr. med. Alessandro Ghiani, 0711-8101-7201, alessandro.ghiani@rbk.de
About this study
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.
- Conditions
- Pulmonary Hypertension, Precapillary Pulmonary Hypertension, Right Heart Catheterisation, Digital Mobility Outcomes
- Being tested
- Accelerometer (measurement of walking activity)
- Keywords
- Digital mobility assessment, Right heart catheterization, Mobility assessment, Digital mobility outcome, Pulmonary hypertension, Pulmonary arterial hypertension, Sensor, Axivity sensor, Precapillary pulmonary hypertension, Walking assessment, Walking test, Physical activity
- Medical subject headings
- Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Accelerometer (measurement of walking activity) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Secondary outcomes (6)
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: 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: 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: 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: 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:
- 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
Measured: 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: 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.
Measured: From enrollment to end of study after the last follow-up visit at 6-12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start19 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 77 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Simon Jäger
- Sponsor type
- University, hospital or other
- Collaborators
- Klinikum Nürnberg, LMU Klinikum, SLK Kliniken Heilbronn GmbH, Robert Bosch Medical Center
- Responsible party
- Sponsor-investigator, Simon Jäger, Paracelsus Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07137260
- Sponsor's protocol ID
- CPN_PMU001
- Status last verified
- Aug 2025
- First submitted
- 9 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Assessment of Real-World Walking Activity in Pulmonary Hypertension: A Prospective Multicenter Trial
- ClinicalTrials.gov ID
- NCT07137260
- Acronym / sponsor ID
- CPN_PMU001
- Conditions
- Pulmonary Hypertension, Precapillary Pulmonary Hypertension, Right Heart Catheterisation, Digital Mobility Outcomes
- Keywords
- Digital mobility assessment, Right heart catheterization, Mobility assessment, Digital mobility outcome, Pulmonary hypertension, Pulmonary arterial hypertension, Sensor, Axivity sensor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 77 participants (estimated)
- Lead sponsor
- Simon JägerUniversity, hospital or other
- Collaborators
- Klinikum Nürnberg, LMU Klinikum, SLK Kliniken Heilbronn GmbH, Robert Bosch Medical Center
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients newly diagnosed with precapillary pulmonary hypertension | – | Device: Accelerometer (measurement of walking activity)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with precapillary pulmonary hypertension and receiving treatment at participating study centres.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Patients newly diagnosed with precapillary pulmonary hypertension |
Primary outcome
Correlation of digital mobility assessments with measured pulmonary arterial pressures
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.
6 secondary outcomes
Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: amount of walking episodes
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).
Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: duration of walking episodes
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).
Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: amount of steps
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 important 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 digital mobility outcomes and disease progression
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).
Investigation of potential confounders
Time frame: From enrollment to end of study after the last follow-up visit at 6-12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension and Precapillary Pulmonary Hypertension, run by Simon Jäger at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Dr. med. Simon Jäger (+49 911-398-2822, simon.jaeger@klinikum-nuernberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of digital mobility assessments with measured pulmonary arterial pressures (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.