Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-25 @ 2:05 AM
NCT ID:
NCT07137260
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07137260
Study Brief:
Protocol Section:
NCT07137260