RecruitingNCT07137260

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

Sponsor

Simon Jäger

Enrollment

77 participants

Start Date

Apr 19, 2024

Study Type

OBSERVATIONAL

Conditions

Pulmonary Hypertension Precapillary Pulmonary Hypertension Right Heart Catheterisation Digital Mobility Outcomes

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria7

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 Criteria8

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

Interventions

DEVICEAccelerometer (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.