A Study of Real-world Cohort of Pulmonary Arterial Hypertension (PAH) Participants
NCT ID: NCT04955990
Last Updated: 2025-02-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE4
232 participants
INTERVENTIONAL
2021-10-14
2022-12-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Participants with PAH
Participants with pulmonary arterial hypertension (PAH) who newly initiate any PAH therapy(ies) at the index date (date when a participant starts the first new PAH therapy after baseline assessments) in a routine clinical setting, either as first-line therapy, as replacement therapies, as concomitant with other PAH therapies, or have already been receiving macitentan 10 milligrams (mg) for at least 3 months prior to the index date. The primary data source for this study will be the medical records of each participant.
PAH Therapies
No Drug will be administered as part of this study. Real world data will be collected in participants who newly initiate PAH therapies in routine clinical setting or have already been receiving macitentan 10 mg for at least 3 months prior to the index date.
Interventions
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PAH Therapies
No Drug will be administered as part of this study. Real world data will be collected in participants who newly initiate PAH therapies in routine clinical setting or have already been receiving macitentan 10 mg for at least 3 months prior to the index date.
Eligibility Criteria
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Inclusion Criteria
* PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to or at the index date fulfilling all of the criteria below: a) Mean pulmonary artery pressure greater than (\>) 20 millimeters of mercury (mm Hg), and b) Pulmonary artery wedge pressure or left ventricular end diastolic pressure less than or equal to (\<=) 15 mm Hg, and c) Pulmonary vascular resistance greater than or equal to (\>=) 3 Wood Units (that is, \>= 240 dynes seconds per centimeters penta \[dyn∙sec/cm\^5\])
* Participant satisfies either a or b: a) Newly initiating 1 or more PAH therapy(ies) (as monotherapy or add-on therapy) at index date. These newly initiated PAH therapies should not have been used within 3 months of the index date; b) Taking macitentan 10 milligrams (mg) therapy (as monotherapy or in combination) with no changes in PAH therapy for within 3 months prior to the index date
* All mandated assessments must be performed and recorded at the baseline visit before the initiation of the new PAH therapy at the index date or enrollment in the study.
* For the pulmonary arterial hypertension-symptoms and impact (PAH-SYMPACT) substudy only: Participants initiating any endothelin receptor antagonist (ERA) or phosphodiesterase-5 inhibitor therapies at index date or at therapy change must provide consent to enroll in the optional PAH-SYMPACT substudy. Refusal to give consent for the optional PAH-SYMPACT substudy will not exclude a participant from participation in the main study
Exclusion Criteria
* Currently enrolled in an observational study sponsored or managed by a Janssen company
* Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1 second \[FEV1\] / forced vital capacity \[FVC\] \<70%; and FEV1 \<60% of predicted after bronchodilator administration) in participants with a known or suspected history of significant lung disease, as documented by a spirometry test performed within 1 year prior to screening
* Presence of moderate or severe restrictive lung disease (for example, total lung capacity or FVC \<60 percent \[%\] of normal predicted value) in participants with a known or suspected history of significant lung disease, as documented by a spirometry test performed within 1 year prior to screening
18 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Actelion Clinical Trial
Role: STUDY_DIRECTOR
Actelion
Locations
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Bay Area Cardiology Associates, P.A. - Brandon Office
Brandon, Florida, United States
University of South Florida
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
University Of Iowa - Hospitals & Clinics
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
University of Maryland
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
University of Cinncinnati Physicans- UC Health Physicnas Office
Cincinnati, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Houston Methodist Hospital
Houston, Texas, United States
Instituto Cardiovascular de Rosario
Rosario, , Argentina
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, , Brazil
Universidade Estadual Paulista 'Julio De Mesquita Filho'
Botucatu, , Brazil
Irmandade Santa Casa de Misericordia de Porto Alegre
Porto Alegre, , Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, , Brazil
University of Alberta Hospital
Edmonton, Alberta, Canada
London Health Sciences Centre Victoria Hospital
London, Ontario, Canada
Beijing Anzhen Hospital
Beijing, , China
Beijing Fuwai Hospital
Beijing, , China
Peking Union Medical College Hospital
Beijing, , China
West China Hospital Sichuan University
Chengdu, , China
Shanghai Pulmonary Hospital
Shanghai, , China
Universitatsklinikum Bonn
Bonn, , Germany
Ospedale S.Giuseppe, Gruppo MultiMedica
Milan, , Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavi
Pavia, , Italy
Universita degli Studi di Roma 'La Sapienza' - Umberto I Policlinico di Roma
Rome, , Italy
National Hospital Organization Okayama Medical Center
Okayama, , Japan
National Heart Institute
Kuala Lumpur, , Malaysia
Vrije Universiteit Amsterdam (VU)
Amsterdam, , Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Krakowski Szpital Specjalistyczny im Jana Pawla II
Krakow, , Poland
Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego SPZOZ
Lublin, , Poland
CardioPulmonary Research, PSC
Guaynabo, , Puerto Rico
National Heart Centre (NHC) Singapore
Singapore, , Singapore
Pusan National University Hospital
Busan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Severance Hospital Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, , South Korea
Hosp. Univ. 12 de Octubre
Madrid, , Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Majadahonda, , Spain
Hosp. Univ. Marques de Valdecilla
Santander, , Spain
Sahlgrenska Universitetsjukhuset
Gothenburg, , Sweden
Royal Free Hospital
London, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Papworth Hospital, Cambridge University
Papworth Everard, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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Other Identifiers
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67896062PAH4005
Identifier Type: OTHER
Identifier Source: secondary_id
CR109007
Identifier Type: -
Identifier Source: org_study_id
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