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NCT04567602Completed

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

Non-Interventional Study on Pulmonary Arterial Hypertension Patients Treated With Macitentan or Selexipag: Experience From an Italian Cohort (INSPECTIO)

Source: ClinicalTrials.gov · Last updated 25 Jun 2025

Brief summary (registry, in English)

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).

Status (registry)
Completed
Study type
Observational
Enrollment
372 (actual)
First submitted
23 Sept 2020
Start date
6 Oct 2020
Primary completion date
25 Jan 2024
Lead sponsor
Janssen-Cilag S.p.A.
NCT number
NCT04567602

What you commit to

  • Study type: Observational
  • Participants enrolled: 372
  • From 6 Oct 2020 to the primary completion date, 25 Jan 2024
  • 30 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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

Other

  • Participants in Group 1 that are responders to the vasoreactivity test
  • Participants currently enrolled in an interventional study

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Generale Regionale F. Miulli
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Acquaviva delle FontiItalyUnknown status
A.O. Universitaria Ospedali Riuniti di Ancona
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AnconaItalyUnknown status
Ospedale Di Venere
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BariItalyUnknown status
Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari
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BariItalyUnknown status
Ospedale di Bolzano
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BolzanoItalyUnknown status
ASST Spedali Civili Brescia
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BresciaItalyUnknown status
Azienda Ospedaliera G. Brotzu
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CagliariItalyUnknown status
AO di Catanzaro Pugliese Ciaccio
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CatanzaroItalyUnknown status
ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
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ChietiItalyUnknown status
AOU Careggi
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FlorenceItalyUnknown status
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
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FoggiaItalyUnknown status
Ospedale Policlinico San Martino IRCCS
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GenovaItalyUnknown status
Presidio Ospedaliero di Ivrea
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IvreaItalyUnknown status
IRCCS Ospedale San Raffaele
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MilanItalyUnknown status
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyUnknown status
Centro Cardiologico Monzino
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MilanItalyUnknown status
Ospedale Monaldi
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NaplesItalyUnknown status
Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
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NovaraItalyUnknown status
AOU di Padova
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PadovaItalyUnknown status
ISMETT Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione
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PalermoItalyUnknown status
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyUnknown status
Fondazione Toscana Gabriele Monasterio CNR
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PisaItalyUnknown status
UOC Oncologia Ospedale Provinciale di Macerata
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Province of MacerataItalyUnknown status
Policinico A Gemelli
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RomaItalyUnknown status
AOU Policlinico Umberto I
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RomaItalyUnknown status
IRCCS Policlinico San Donato
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San Donato MilaneseItalyUnknown status
Presidio SS Annunziata AOU Sassari
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SassariItalyUnknown status
Azienda Ospedaliera Città della Salute e della Scienza di Torino
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TorinoItalyUnknown status
ASUI Santa Maria della Misericordia di Udine
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UdineItalyUnknown status
Ospedale Borgo Roma
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VeronaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.