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

June 19, 2025 updated by: Janssen-Cilag S.p.A.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
372

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Acquaviva Delle Fonti, Italy, 70021
        • Generale Regionale F. Miulli
      • Ancona, Italy, 60126
        • A.O. Universitaria Ospedali Riuniti di Ancona
      • Bari, Italy, 70124
        • Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari
      • Bari, Italy, 70131
        • Ospedale Di Venere
      • Bolzano, Italy, 39100
        • Ospedale di Bolzano
      • Brescia, Italy, 25123
        • ASST Spedali Civili Brescia
      • Cagliari, Italy, 09134
        • Azienda Ospedaliera G. Brotzu
      • Catanzaro, Italy, 88100
        • AO di Catanzaro Pugliese Ciaccio
      • Chieti, Italy, 66100
        • ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti
      • Firenze, Italy, 50134
        • AOU Careggi
      • Foggia, Italy, 71122
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia
      • Genova, Italy, 16132
        • Ospedale Policlinico San Martino IRCCS
      • Ivrea, Italy, 10015
        • Presidio ospedaliero di Ivrea
      • Macerata, Italy, 62100
        • UOC Oncologia Ospedale Provinciale di Macerata
      • Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milano, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
      • Milano, Italy, 20138
        • Centro Cardiologico Monzino
      • Napoli, Italy, 80131
        • Ospedale Monaldi
      • Novara, Italy, 28100
        • Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara
      • Padova, Italy, 35128
        • AOU di Padova
      • Palermo, Italy, 90127
        • ISMETT Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo
      • Pisa, Italy, 56124
        • Fondazione Toscana Gabriele Monasterio CNR
      • Roma, Italy, 00168
        • Policinico A Gemelli
      • Roma, Italy, 00161
        • AOU Policlinico Umberto I
      • San Donato Milanese, Italy, 20097
        • IRCCS Policlinico San Donato
      • Sassari, Italy, 07100
        • Presidio SS Annunziata AOU Sassari
      • Torino, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
      • Udine, Italy, 33100
        • ASUI Santa Maria della Misericordia di Udine
      • Verona, Italy, 37134
        • Ospedale Borgo Roma

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Study population consist of participants with confirmed diagnosis of PAH.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: PAH medication
There will be no specific interventions.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in the Number of the Non-Invasive Low-Risk Criteria to 12 Months
Time Frame: Baseline and 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.
Baseline and 12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Improved, Stable or Worsened Risk profile from Baseline to 12 and 24 Months
Time Frame: Baseline up 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.
Baseline up to 12 and 24 Months
Change in Progression in the Number of Participants with Low/High Intermediate Risk
Time Frame: Baseline up to 24 Months
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.
Baseline up to 24 Months
Change from Baseline in 6MWD
Time Frame: Baseline up to 24 Months
Change from baseline in 6MWD will be reported.
Baseline up to 24 Months
Change from Baseline in BNP or NT-proBNP
Time Frame: Baseline up to 24 Months
Change from baseline in BNP or NT-proBNP will be reported.
Baseline up to 24 Months
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
Time Frame: Baseline 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.
Baseline up to 12 and 24 Months
Adherence to European Society of Cardiology and European Respiratory Society (ESC/ERS) guidelines and 6th World Symposium on Pulmonary Hypertension (WSPH)
Time Frame: Up to 24 Months
Adherence to ESC/ERS guidelines and 6th WSPH will be reported.
Up to 24 Months
Change from Baseline in Echocardiographic Parameters
Time Frame: Baseline up to 24 Months
Change in echocardiographic parameters will be reported as assessed by echocardiogram.
Baseline up to 24 Months
Change from Baseline in Hemodynamic Parameters
Time Frame: Baseline up to 24 Months
Change in hemodynamic parameters will be reported.
Baseline up to 24 Months
Hospitalization Rate due to Worsening of PAH
Time Frame: Up to 24 Months
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.
Up to 24 Months
Overall Survival (OS)
Time Frame: Up to 24 Months
OS is defined as the duration/time from the start of study treatment to date of death due to any cause.
Up to 24 Months
Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured with Emphasis-10 Questionnaire
Time Frame: Baseline up to 24 Months
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.
Baseline up to 24 Months
Change from Baseline in Participants with Narrative plots
Time Frame: Baseline and 12 Months
Participants will be invited to fill in two narrative plots; one at the enrollment visit and one at the month 12 visit.
Baseline and 12 Months
Change from Baseline in Caregivers with Narrative Plots
Time Frame: Baseline and 12 Months
Caregivers will be invited to fill in two narrative plots; one at the enrollment visit and one at the month 12 visit.
Baseline and 12 Months
Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
Time Frame: Up to 24 Months
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.
Up to 24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen-Cilag S.p.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial, Janssen-Cilag S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 6, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 25, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 5, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR108855
  • 67896049PAH4009 (Other Identifier: Janssen-Cilag S.p.A., Italy)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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