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

NCT07137260 | Recruiting

• 1 other identifier: CPN_PMU001
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 4

Brief 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 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

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

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (6)

• Description of the general daily walking behaviour of patients with precapillary pulmonary hypertension: amount of walking episodes

  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

  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

  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

  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

  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).

Study Arms (1)

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.

Device: Accelerometer (measurement of walking activity)

Interventions

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.

Patients newly diagnosed with precapillary pulmonary hypertension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with precapillary pulmonary hypertension and receiving treatment at participating study centres.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Simon Jäger: lead
• Klinikum Nürnberg: collaborator
• LMU Klinikum: collaborator
• SLK Kliniken Heilbronn GmbH: collaborator
• Robert Bosch Medical Center: collaborator

Study Sites (4)

Robert Bosch Hospital

Stuttgart, Baden-Wurttemberg, 70376, Germany

RECRUITING

Internal Medicine Clinic V, Ludwig-Maximilians-University Clinic

Munich, Bavaria, 81377, Germany

RECRUITING

Klinikum Nuremberg

Nuremberg, Bavaria, 90419, Germany

RECRUITING

SLK-Kliniken Heilbronn GmbH - Fachklinik Löwenstein

Löwenstein, 74245, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Behavior

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head: Institute of Clinical Pharmacology

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: August 22, 2025
• Study Start: April 19, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (4)