A Study of Pulmonary Arterial Hypertension Participants Treated With Macitentan or Selexipag (INSPECTIO)

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Pulmonary Arterial Hypertension

Treatments: Drug: PAH medication

Study type: Observational

Funder types: Industry

Identifiers

NCT04567602

67896049PAH4009 (Other Identifier)

CR108855

Details and patient eligibility

About

The purpose of the study is to evaluate the change from baseline to 12 months after study enrollment in the number of the following non-invasive risk criteria: World Health Organization Functional Class (WHO/FC), 6-minute walk distance (6MWD), Brain Natriuretic Peptide (BNP) or N-terminal pro-brain Natriuretic Peptide (NT-proBNP).

Enrollment: 372 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants in the clinical classification of pulmonary hypertension Group 1 (PAH)
• Participants with idiopathic, heritable and associated forms of PAH (connective tissue disease, congenital heart disease corrected at least 1-year ago, human immunodeficiency virus infection, drug use or toxin, and porto-pulmonary)
• Confirmed diagnosis of PAH with hemodynamic study right heart catheterization (RHC) at enrolment or at latest follow-up (not later than twelve months from enrolment date)
• Participants with a low or intermediate mortality risk profile, as per clinical judgement based on a multiparametric approach including clinical, functional exercise, right ventricular function and hemodynamic parameters
• Participants currently in treatment with selexipag and/or macitentan (in monotherapy or in combination therapy)

Exclusion criteria

• Participants in Group 1 that are responders to the vasoreactivity test
• Participants with pulmonary veno-occlusive disease (PVOD), defined on the basis of the following chest findings at high-resolution computed tomography (HRCT): centrilobular ground-glass opacities, smooth thickening of interlobular septa, mediastinal lymph node enlargement
• Participants already in treatment with subcutaneous/intravenous prostanoids. Iloprost interventional (IV) (treatment of digital ulcers in systemic sclerosis [SSc] participants according to european league against rheumatism [EULAR] guidelines) is allowed
• Participants currently enrolled in an interventional study

Trial design

372 participants in 1 patient group

Participants with PAH

Description:

Participants with confirmed diagnosis of pulmonary arterial hypertension (PAH) will be enrolled in the study and the data will be collected and observed to describe the application of European ESC/ERS guidelines and related 6th WSPH proceedings on risk assessment and related treatment strategy, in clinical practice.

Treatment:

Drug: PAH medication