An International, Non-Drug Interventional, Real-world Cohort of PAH Patients Newly Initiating PAH Therapy With Guideline-directed Assessments of Disease Severity

TerminadoFase 4ClinicalTrials.gov

ID: NCT04955990Tipo: INTERVENTIONALInicio: 14 de oct de 2021Fin estimado: 20 de dic de 2022

Traducción no disponible, mostrando original

Resumen

This study is designed to describe pulmonary arterial hypertension (PAH) participants in terms of their clinical characteristics, therapies used, disease progression, and outcomes (example, death, hospitalization, risk category for predicted mortality risk, and patient-reported outcomes \[PROs\]) in real-world clinical practice. This study will collect high-quality real-world data that may be used as a stand-alone dataset or in combination with other studies to address relevant research questions (example, serve as an external control dataset to another study) to support development and access to PAH therapies, as well as to contribute to the knowledge base of PAH through publications.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Symptomatic pulmonary arterial hypertension (PAH) in any PAH subtype
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

Criterios de exclusión

Participants enrolled in any interventional clinical trial with an investigational therapy in the 3-month period prior to index date
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

Intervenciones

other

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.

Ubicaciones

Instituto Cardiovascular de Rosario

Rosario, Argentina

Patrocinadores

PrincipalActelion

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