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
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Generale Regionale F. Miulli Coordinator of this site? Confirm its status | Acquaviva delle Fonti | Italy | Unknown status |
| A.O. Universitaria Ospedali Riuniti di Ancona Coordinator of this site? Confirm its status | Ancona | Italy | Unknown status |
| Ospedale Di Venere Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Consorziale Policlinico Di Bari Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| Ospedale di Bolzano Coordinator of this site? Confirm its status | Bolzano | Italy | Unknown status |
| ASST Spedali Civili Brescia Coordinator of this site? Confirm its status | Brescia | Italy | Unknown status |
| Azienda Ospedaliera G. Brotzu Coordinator of this site? Confirm its status | Cagliari | Italy | Unknown status |
| AO di Catanzaro Pugliese Ciaccio Coordinator of this site? Confirm its status | Catanzaro | Italy | Unknown status |
| ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti Coordinator of this site? Confirm its status | Chieti | Italy | Unknown status |
| AOU Careggi Coordinator of this site? Confirm its status | Florence | Italy | Unknown status |
| Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia Coordinator of this site? Confirm its status | Foggia | Italy | Unknown status |
| Ospedale Policlinico San Martino IRCCS Coordinator of this site? Confirm its status | Genova | Italy | Unknown status |
| Presidio Ospedaliero di Ivrea Coordinator of this site? Confirm its status | Ivrea | Italy | Unknown status |
| IRCCS Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Centro Cardiologico Monzino Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Ospedale Monaldi Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
| Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara Coordinator of this site? Confirm its status | Novara | Italy | Unknown status |
| AOU di Padova Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| ISMETT Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione Coordinator of this site? Confirm its status | Palermo | Italy | Unknown status |
| Fondazione IRCCS Policlinico San Matteo Coordinator of this site? Confirm its status | Pavia | Italy | Unknown status |
| Fondazione Toscana Gabriele Monasterio CNR Coordinator of this site? Confirm its status | Pisa | Italy | Unknown status |
| UOC Oncologia Ospedale Provinciale di Macerata Coordinator of this site? Confirm its status | Province of Macerata | Italy | Unknown status |
| Policinico A Gemelli Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| AOU Policlinico Umberto I Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
| IRCCS Policlinico San Donato Coordinator of this site? Confirm its status | San Donato Milanese | Italy | Unknown status |
| Presidio SS Annunziata AOU Sassari Coordinator of this site? Confirm its status | Sassari | Italy | Unknown status |
| Azienda Ospedaliera Città della Salute e della Scienza di Torino Coordinator of this site? Confirm its status | Torino | Italy | Unknown status |
| ASUI Santa Maria della Misericordia di Udine Coordinator of this site? Confirm its status | Udine | Italy | Unknown status |
| Ospedale Borgo Roma Coordinator of this site? Confirm its status | Verona | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.