A Prospective Non-interventional Observational Study to Observe Long-term Treatment and Outcomes in Pulmonary Arterial Hypertension (PAH) Patients (TripleTRE-NIS)

AOP Orphan

Status: Invitation-only

Conditions: Pulmonary Arterial Hypertension

Study type: Observational

Funder types: Industry

Identifiers

NCT06445673

TREV1-10P.NIS

Details and patient eligibility

About

The goal of this observational study is to learn about the long-term development and outcomes of different treatment patterns of patients who initially participated in the TripleTRE study.

The primary objective of this non-interventional follow-up study is to assess the long-term real-world clinical outcomes, including disease progression and survival rates, in patients who initially participated in and completed the randomized TripleTRE trial.

Planned observation duration per patient is a minimum of 3 years.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients previously participating in the randomized TripleTRE trial who are able and willing to provide a signed informed consent for study participation in NIS

Exclusion criteria

1. Lost to follow-up patients of TripleTRE study
2. Patients who discontinued all medicinal PAH treatments (e.g. after successful lung transplantation)
3. Patients who withdrew from the initial TripleTRE trial due to significant non-compliance with trial requirements (not adhering to therapy, not coming to hospital visits)

Trial design

110 participants in 1 patient group

TripleTRE NIS patients

Description:

all patients previously treated within the TripleTRE trial who are willing to participate in this NIS