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)