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

Simon Jäger

Status: Enrolling

Conditions: Right Heart Catheterisation; Digital Mobility Outcomes; Precapillary Pulmonary Hypertension; Pulmonary Hypertension

Treatments: Device: Accelerometer (measurement of walking activity)

Study type: Observational

Funder types: Other

Identifiers

NCT07137260

CPN_PMU001

Details and patient eligibility

About

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.

Enrollment: 77 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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 design

77 participants in 1 patient group

Patients newly diagnosed with precapillary pulmonary hypertension

Description:

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.

Treatment:

Device: Accelerometer (measurement of walking activity)