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

NCT ID: NCT04567602

Last Updated: 2025-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

372 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-06

Study Completion Date

2024-03-05

Brief Summary

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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).

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Detailed Description

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Conditions

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Pulmonary Arterial Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with PAH

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.

PAH medication

Intervention Type DRUG

There will be no specific interventions.

Interventions

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PAH medication

There will be no specific interventions.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Janssen-Cilag S.p.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janssen-Cilag S.p.A., Italy Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag S.p.A.

Locations

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Generale Regionale F. Miulli

Acquaviva delle Fonti, , Italy

Site Status

A.O. Universitaria Ospedali Riuniti di Ancona

Ancona, , Italy

Site Status

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, , Italy

Site Status

Ospedale Di Venere

Bari, , Italy

Site Status

Ospedale di Bolzano

Bolzano, , Italy

Site Status

ASST Spedali Civili Brescia

Brescia, , Italy

Site Status

Azienda Ospedaliera G. Brotzu

Cagliari, , Italy

Site Status

AO di Catanzaro Pugliese Ciaccio

Catanzaro, , Italy

Site Status

ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti

Chieti, , Italy

Site Status

AOU Careggi

Florence, , Italy

Site Status

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, , Italy

Site Status

Ospedale Policlinico San Martino IRCCS

Genova, , Italy

Site Status

Presidio Ospedaliero di Ivrea

Ivrea, , Italy

Site Status

UOC Oncologia Ospedale Provinciale di Macerata

Macerata, , Italy

Site Status

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, , Italy

Site Status

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status

Centro Cardiologico Monzino

Milan, , Italy

Site Status

Ospedale Monaldi

Napoli, , Italy

Site Status

Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

Novara, , Italy

Site Status

AOU di Padova

Padua, , Italy

Site Status

ISMETT Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione

Palermo, , Italy

Site Status

Fondazione IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

Fondazione Toscana Gabriele Monasterio CNR

Pisa, , Italy

Site Status

AOU Policlinico Umberto I

Roma, , Italy

Site Status

Policinico A Gemelli

Roma, , Italy

Site Status

IRCCS Policlinico San Donato

San Donato Milanese, , Italy

Site Status

Presidio SS Annunziata AOU Sassari

Sassari, , Italy

Site Status

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , Italy

Site Status

ASUI Santa Maria della Misericordia di Udine

Udine, , Italy

Site Status

Ospedale Borgo Roma

Verona, , Italy

Site Status

Countries

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Italy

Other Identifiers

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67896049PAH4009

Identifier Type: OTHER

Identifier Source: secondary_id

CR108855

Identifier Type: -

Identifier Source: org_study_id

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