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

Sponsor

Janssen-Cilag S.p.A. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04567602

Collaborator

(none)

200

Enrollment

Locations

50.8

Anticipated Duration (Months)

5.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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 (NT-proBNP).

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Arterial Hypertension	Drug: PAH medication

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 6, 2020

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants with Improved, Stable or Worsened Risk profile from Baseline to 12 and 24 Months [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.
Change in Progression in the Number of Participants with Low/High Intermediate Risk [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.
Change from Baseline in 6MWD [Baseline up to 24 Months]
Change from baseline in 6MWD will be reported.
Change from Baseline in BNP or NT-proBNP [Baseline up to 24 Months]
Change from baseline in BNP or NT-proBNP will be reported.
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 [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.
Adherence to European Society of Cardiology and European Respiratory Society (ESC/ERS) guidelines and 6th World Symposium on Pulmonary Hypertension (WSPH) [Up to 24 Months]
Adherence to ESC/ERS guidelines and 6th WSPH will be reported.
Change from Baseline in Echocardiographic Parameters [Baseline up to 24 Months]
Change in echocardiographic parameters will be reported as assessed by echocardiogram.
Change from Baseline in Hemodynamic Parameters [Baseline up to 24 Months]
Change in hemodynamic parameters will be reported.
Hospitalization Rate due to Worsening of PAH [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.
Overall Survival (OS) [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.
Change from Baseline in Health-Related Quality of Life (HRQoL) as Measured with Emphasis-10 Questionnaire [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.
Change from Baseline in Participants with Narrative plots [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.
Change from Baseline in Caregivers with Narrative Plots [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.
Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 mortality risk profile parameters in low or intermediate range
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 with at least one high-risk parameter (invasive and/or non-invasive)
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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Generale Regionale F. Miulli	Acquaviva Delle Fonti	Italy	70021
2	A.O. Universitaria Ospedali Riuniti di Ancona	Ancona	Italy	60126
3	Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy	70124
4	Ospedale Di Venere	Bari	Italy	70131
5	Ospedale di Bolzano	Bolzano	Italy	39100
6	ASST Spedali Civili Brescia	Brescia	Italy	25123
7	Azienda Ospedaliera G. Brotzu	Cagliari	Italy	09134
8	AO di Catanzaro 'Pugliese Ciaccio'	Catanzaro	Italy	88100
9	ASL2 Lanciano - Vasto - Chieti - Ospedale 'SS Annunziata' di Chieti	Chieti	Italy	66100
10	AOU Careggi	Firenze	Italy	50134
11	Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia	Foggia	Italy	71122
12	Ospedale Policlinico San Martino IRCCS	Genova	Italy	16132
13	Presidio Ospedaliero di Ivrea	Ivrea	Italy	10015
14	UOC Oncologia Ospedale Provinciale di Macerata	Macerata	Italy	62100
15	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milano	Italy	20122
16	IRCCS Ospedale San Raffaele	Milano	Italy	20132
17	Centro Cardiologico Monzino	Milano	Italy	20138
18	AOU Di Modena, Policlinico Di Modena	Modena	Italy	41125
19	Ospedale Monaldi	Napoli	Italy	80131
20	Università del Piemonte Orientale - Ospedale Maggiore della Carità di Novara	Novara	Italy	28100
21	Ospedale San Francesco	Nuoro	Italy	8100
22	AOU di Padova	Padova	Italy	35128
23	ISMETT Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione	Palermo	Italy	90127
24	Fondazione IRCCS Policlinico San Matteo	Pavia	Italy	27100
25	AUSL DI PIACENZA - Ospedale Guglielmo da Saliceto	Piacenza	Italy	29121
26	Fondazione Toscana Gabriele Monasterio CNR	Pisa	Italy	56124
27	Arcispedale Santa Maria Nuova - IRCCS	Reggio Emilia	Italy	42123
28	AOU Policlinico Umberto I	Roma	Italy	00161
29	Policinico A Gemelli	Roma	Italy	00168
30	IRCCS Policlinico San Donato	San Donato Milanese	Italy	20097
31	Presidio SS Annunziata AOU Sassari	Sassari	Italy	07100
32	Azienda Ospedaliera Città della Salute e della Scienza di Torino	Torino	Italy	10126
33	Ospedale Santa Chiara Trento	Trento	Italy	38123
34	ASUI Santa Maria della Misericordia di Udine	Udine	Italy	33100
35	Ospedale Borgo Roma	Verona	Italy	37134

Sponsors and Collaborators

Janssen-Cilag S.p.A.

Investigators

Study Director: Janssen-Cilag S.p.A., Italy Clinical Trial, Janssen-Cilag S.p.A.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Janssen-Cilag S.p.A.

ClinicalTrials.gov Identifier:

NCT04567602

Other Study ID Numbers:

CR108855
67896049PAH4009

First Posted:

Sep 28, 2020

Last Update Posted:

Aug 17, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pulmonary Arterial Hypertension

Familial Primary Pulmonary Hypertension

Hypertension

Study Results

No Results Posted as of Aug 17, 2022