Overview

A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants

Status:
Not yet recruiting
Trial end date:
2027-10-24
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to describe the time to all-cause death and time to death due to pulmonary arterial hypertension (PAH) or first hospitalization due to PAH in the overall study population and within each cohort.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Actelion
Criteria
Inclusion Criteria:

- Clinically diagnosed pulmonary arterial hypertension (PAH) in any PAH subtype

- Hemodynamic evaluation at rest at any time prior to or at the index date fulfilling
all of the criteria below: a) Mean pulmonary artery pressure greater than (>) 20
millimeters of mercury (mmHg), and b) Pulmonary artery wedge pressure or left
ventricular end diastolic pressure less than or equal to (<=) 15 mmHg, and c)
Pulmonary vascular resistance greater than or equal to (>=) 3 Wood Units (that is, >=
240 dynes seconds per centimeters penta [dyn∙sec/cm^5])

- Newly initiating 1 or more PAH therapy(ies) at index date

- All mandated assessments must be performed and recorded at the baseline visit before
the initiation of the new PAH therapy at the index date

- For the pulmonary arterial hypertension-symptoms and impact (PAH-SYMPACT) substudy
only: Participants initiating any endothelin receptor antagonist (ERA) or
phosphodiesterase-5 inhibitor therapies at index date or at therapy change must
provide consent to enroll in the optional PAH-SYMPACT substudy. Refusal to give
consent for the optional PAH-SYMPACT substudy will not exclude a participant from
participation in the main study

Exclusion Criteria:

- Participants enrolled in any interventional clinical trial with an investigational
therapy in the 3-month period prior to index date

- Any PAH therapy initiated at index date was used by the participant (including
different route of administration of the same compound) within 3 months prior to index
date for any reason. (Administration for vasoreactivity testing is permitted)