A Study of Real-world Cohort of Pulmonary Arterial Hypert... | NCT04955990

ID	Type	Description	Link
67896062PAH4005	Other Identifier	Actelion

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participants with PAH	Experimental	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.	Other: PAH Therapies

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PAH Therapies	Other	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to all Cause Death	Time to all cause death will be reported. All-cause death defined as deaths due to any cause.	Up to 6 years
Time to Death due to Pulmonary Arterial Hypertension (PAH) or First Hospitalization due to PAH	Time to death due to PAH or first hospitalization due to PAH will be reported.	Up to 6 years

Secondary Outcomes

Measure	Description	Time Frame
Time to Death due to PAH	Time to death due to PAH will be reported.	Up to 6 years
Time to First all-cause Hospitalization	Time to first all-cause hospitalization will be reported.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Name	Affiliation	Role
Actelion Clinical Trial	Actelion	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Bay Area Cardiology Associates, P.A. - Brandon Office		Brandon	Florida	33511	United States
University of South Florida

IPD Sharing Statement Module

ID	Term
D006976	Hypertension, Pulmonary
D008171	Lung Diseases
D012140	Respiratory Tract Diseases