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Pulmonary Arterial HypertensionINSPECTIONCT04567602

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

An observational study of Pulmonary Arterial Hypertension, run by Janssen-Cilag S.p.A. at 30 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
PAH medication
How many people
372 participants
Where
30 sitesItaly
Study dates
6 Oct 2020to 5 Mar 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Study population consist of participants with confirmed diagnosis of PAH.

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

30 sites in 1 country.

30 sites in 1 country

Italy30 sites

  • Generale Regionale F. Miulli

    Acquaviva delle Fonti, 70021

  • A.O. Universitaria Ospedali Riuniti di Ancona

    Ancona, 60126

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

    Bari, 70124

  • Ospedale Di Venere

    Bari, 70131

  • Ospedale di Bolzano

    Bolzano, 39100

  • ASST Spedali Civili Brescia

    Brescia, 25123

  • Azienda Ospedaliera G. Brotzu

    Cagliari, 09134

  • AO di Catanzaro Pugliese Ciaccio

    Catanzaro, 88100

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

    Chieti, 66100

  • AOU Careggi

    Florence, 50134

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia

    Foggia, 71122

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132

  • Presidio Ospedaliero di Ivrea

    Ivrea, 10015

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • Centro Cardiologico Monzino

    Milan, 20138

  • Ospedale Monaldi

    Naples, 80131

  • Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara

    Novara, 28100

  • AOU di Padova

    Padova, 35128

  • ISMETT Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione

    Palermo, 90127

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Fondazione Toscana Gabriele Monasterio CNR

    Pisa, 56124

  • UOC Oncologia Ospedale Provinciale di Macerata

    Province of Macerata, 62100

  • AOU Policlinico Umberto I

    Roma, 00161

  • Policinico A Gemelli

    Roma, 00168

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097

  • Presidio SS Annunziata AOU Sassari

    Sassari, 07100

  • Azienda Ospedaliera Città della Salute e della Scienza di Torino

    Torino, 10126

  • ASUI Santa Maria della Misericordia di Udine

    Udine, 33100

  • Ospedale Borgo Roma

    Verona, 37134

Other trials in Italy

About this study

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

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).

Being tested
PAH medication
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PAH medicationDrug

    There will be no specific interventions.

Study groups in NCT04567602
Study groupRoleWhat they receive
Participants with PAHParticipants 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.
Receives: Drug: PAH medication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in the Number of the Non-Invasive Low-Risk Criteria to 12 Months

    Change from baseline in the number of the non-invasive low-risk criteria will be assessed according to the following parameters: world health organization (WHO)/functional class (FC)- I, II, 6-minute walk distance (6MWD) greater than (>) 440 meters (m), and brain natriuretic peptide (BNP) less than (<) 50 nanogram per liter (ng/l) or N-terminal-pro-hormone brain natriuretic Peptide (NT-proBNP) <300 ng/l.

    Measured: Baseline and 12 Months

Secondary outcomes (14)

  1. Number of Participants with Improved, Stable or Worsened Risk profile from Baseline to 12 and 24 Months

    Risk profile is assessed as improved, stable or worsened where improved indicates 1 or more non-invasive parameters from intermediate to low risk profile; stable indicates no change in the parameters; and worsened indicates 1 or more non-invasive parameters move from low or intermediate to intermediate or high range risk.

    Measured: Baseline up to 12 and 24 Months

  2. Change in Progression in the Number of Participants with Low/High Intermediate Risk

    Change in risk profile for the low/high intermediate risk participants according to following cut-off values for low intermediate risk/high intermediate risk, respectively: (6MWD [greater than or equal to [>=] or < 300m], Peak oxygen consumption [VO2] [>= or < 50% predicted], BNP [less than or equal to [<=] or > 175 ng/l], or NT-proBNP [<= or > 850 ng/l], right atrial area [RA] [<= or > 22 centimeter [cm]] and right atrial pressure [RAP] [<= or > 11 millimeter of mercury [mmHg]] or stroke volume index (SVI) (> or <= 38 milliliter per meter square [ml/m2])). The low intermediate risk is defined by a presence of at least three low intermediate parameters and a high intermediate risk is defined by a presence of at least three high intermediate parameters.

    Measured: Baseline up to 24 Months

  3. Change from Baseline in 6MWD

    Change from baseline in 6MWD will be reported.

    Measured: Baseline up to 24 Months

  4. Change from Baseline in BNP or NT-proBNP

    Change from baseline in BNP or NT-proBNP will be reported.

    Measured: Baseline up to 24 Months

  5. Change from Baseline in Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) 2.0 Risk Score up to 12 and 24 Months

    The REVEAL risk calculator determines the risk status and the scores can be defined as: low risk as a score of <= 6, intermediate risk as a score of 7 or 8, and high risk as a score of >= 9 for the survival rates.

    Measured: Baseline up to 12 and 24 Months

  6. Adherence to European Society of Cardiology and European Respiratory Society (ESC/ERS) guidelines and 6th World Symposium on Pulmonary Hypertension (WSPH)

    Adherence to ESC/ERS guidelines and 6th WSPH will be reported.

    Measured: Up to 24 Months

  7. Change from Baseline in Echocardiographic Parameters

    Change in echocardiographic parameters will be reported as assessed by echocardiogram.

    Measured: Baseline up to 24 Months

  8. Change from Baseline in Hemodynamic Parameters

    Change in hemodynamic parameters will be reported.

    Measured: Baseline up to 24 Months

  9. Hospitalization Rate due to Worsening of PAH

    The hospitalization rate due to PAH worsening will be calculated based on the number of participants with at least one hospitalization. The calculation of the rate will be based on the number of events over the whole follow-up time that is exposure time.

    Measured: Up to 24 Months

  10. Overall Survival (OS)

    OS is defined as the duration/time from the start of study treatment to date of death due to any cause.

    Measured: Up to 24 Months

  11. Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured with Emphasis-10 Questionnaire

    The emPHasis-10 is a short and easy questionnaire that consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life.

    Measured: Baseline up to 24 Months

  12. Change from Baseline in Participants with Narrative plots

    Participants will be invited to fill in two narrative plots; one at the enrollment visit and one at the month 12 visit.

    Measured: Baseline and 12 Months

  13. Change from Baseline in Caregivers with Narrative Plots

    Caregivers will be invited to fill in two narrative plots; one at the enrollment visit and one at the month 12 visit.

    Measured: Baseline and 12 Months

  14. Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)

    An AE is any untoward medical occurrence in a participant enrolled in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. An ADR is defined as a response to a medicinal (investigational or non-investigational) product that is noxious and unintended.

    Measured: Up to 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2020
  2. Study start6 Oct 2020
  3. Primary completion25 Jan 2024
  4. Study completion5 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04567602
Sponsor's protocol ID
CR108855
Other IDs
67896049PAH4009
Acronym
INSPECTIO
Status last verified
Jun 2025
First submitted
23 Sep 2020
Last updated
25 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Scelsi L, Badagliacca R, Vicenzi M, Di Poi E, Baldi F, Ameri P, Airo E, Bux F, Lorenzo D, Giuliani L, Perna GP, Bonsante E, D'Agostino C, Raineri C, Agostoni P, Cappuccio A, Greco E, Marini MG, Biancospino M, Uglietti A, De Santis S. Understanding the burden of pulmonary arterial hypertension among patients and caregivers through narrative medicine: data from Italian multicentre observational INSPECTIO study. BMJ Open Respir Res. 2026 Apr 9;13(1):e003377. doi: 10.1136/bmjresp-2025-003377.

    PubMed 41956554

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Arterial Hypertension, run by Janssen-Cilag S.p.A. at 30 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in the Number of the Non-Invasive Low-Risk Criteria to 12 Months (time frame: Baseline and 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04567602, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2025.

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