A Study Of Real-world Cohort Of Pulmonary Arterial Hypertension (PAH) Participants

Overview

About this study

The purpose of this study is to describe the time to all-cause death and time to death due to pulmonary arterial hypertension (PAH) or first hospitalization due to PAH in the overall study population and within each cohort.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Clinically diagnosed pulmonary arterial hypertension (PAH) in any PAH subtype -Hemodynamic evaluation at rest at any time prior to or at the index date fulfilling all of the criteria below:
    • Mean pulmonary artery pressure greater than (>) 20 millimeters of mercury (mmHg); and
    • Pulmonary artery wedge pressure or left ventricular end diastolic pressure less than or equal to (≤) 15 mmHg; and
    • Pulmonary vascular resistance greater than or equal to (≥ 3 Wood Units (that is, ≥ 240 dynes seconds per centimeters penta [dyn∙sec/cm^5]).
  • Newly initiating 1 or more PAH therapy(ies) at 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.
  • 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.
  • Any PAH therapy initiated at index date was used by the participant (including different route of administration of the same compound) within 3 months prior to index date for any reason. (Administration for vasoreactivity testing is permitted).

Eligibility last updated 12/14/21.  Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hilary DuBrock, M.D.

Closed for enrollment

Contact information:

Sleep and Cardiovascular Clinical Research Unit

CPL@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20529187

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