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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04567602
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Janssen-Cilag S.p.A.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Janssen-Cilag S.p.A., Italy Clinical Trial
Principal Investigator Affiliation Janssen-Cilag S.p.A.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Active, not recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Pulmonary Arterial Hypertension
Arms & Interventions

Arms

: 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.

Interventions

Drug: - PAH medication

There will be no specific interventions.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Generale Regionale F. Miulli, Acquaviva Delle Fonti, Italy

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Address

Generale Regionale F. Miulli

Acquaviva Delle Fonti, , 70021

Ancona, Italy

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Address

A.O. Universitaria Ospedali Riuniti di Ancona

Ancona, , 60126

Bari, Italy

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Address

Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

Bari, , 70124

Ospedale Di Venere, Bari, Italy

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Ospedale Di Venere

Bari, , 70131

Ospedale di Bolzano, Bolzano, Italy

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Ospedale di Bolzano

Bolzano, , 39100

ASST Spedali Civili Brescia, Brescia, Italy

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Address

ASST Spedali Civili Brescia

Brescia, , 25123

Azienda Ospedaliera G. Brotzu, Cagliari, Italy

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Azienda Ospedaliera G. Brotzu

Cagliari, , 09134

AO di Catanzaro Pugliese Ciaccio, Catanzaro, Italy

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Address

AO di Catanzaro Pugliese Ciaccio

Catanzaro, , 88100

Chieti, Italy

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Address

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

Chieti, , 66100

AOU Careggi, Firenze, Italy

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AOU Careggi

Firenze, , 50134

Foggia, Italy

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Address

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

Foggia, , 71122

Ospedale Policlinico San Martino IRCCS, Genova, Italy

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Ospedale Policlinico San Martino IRCCS

Genova, , 16132

Presidio Ospedaliero di Ivrea, Ivrea, Italy

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Address

Presidio Ospedaliero di Ivrea

Ivrea, , 10015

Macerata, Italy

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UOC Oncologia Ospedale Provinciale di Macerata

Macerata, , 62100

Milano, Italy

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Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milano, , 20122

IRCCS Ospedale San Raffaele, Milano, Italy

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Address

IRCCS Ospedale San Raffaele

Milano, , 20132

Centro Cardiologico Monzino, Milano, Italy

Status

Address

Centro Cardiologico Monzino

Milano, , 20138

Ospedale Monaldi, Napoli, Italy

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Address

Ospedale Monaldi

Napoli, , 80131

Novara, Italy

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Address

Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

Novara, , 28100

AOU di Padova, Padova, Italy

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AOU di Padova

Padova, , 35128

Palermo, Italy

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Address

ISMETT Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione

Palermo, , 90127

Fondazione IRCCS Policlinico San Matteo, Pavia, Italy

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Address

Fondazione IRCCS Policlinico San Matteo

Pavia, , 27100

Pisa, Italy

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Address

Fondazione Toscana Gabriele Monasterio CNR

Pisa, , 56124

AOU Policlinico Umberto I, Roma, Italy

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Address

AOU Policlinico Umberto I

Roma, , 00161

Policinico A Gemelli, Roma, Italy

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Address

Policinico A Gemelli

Roma, , 00168

IRCCS Policlinico San Donato, San Donato Milanese, Italy

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Address

IRCCS Policlinico San Donato

San Donato Milanese, , 20097

Presidio SS Annunziata AOU Sassari, Sassari, Italy

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Address

Presidio SS Annunziata AOU Sassari

Sassari, , 07100

Torino, Italy

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Address

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Torino, , 10126

Udine, Italy

Status

Address

ASUI Santa Maria della Misericordia di Udine

Udine, , 33100

Ospedale Borgo Roma, Verona, Italy

Status

Address

Ospedale Borgo Roma

Verona, , 37134

For more information, please contact PHA at Research@PHAssociation.org and refer to the terms of service below.

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