United States Pulmonary Hypertension Scientific Registry (USPHSR)

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 16-006159
    Sponsor Protocol Number: 16-006159

About this study

The purpose of the United States Pulmonary Hypertension Scientific Registry (USPHSR) will be to promote a greater understanding of PAH in an era of genetic discoveries, the study of the physical make up of individual people, and new treatments through education and collaborative assessment of information among pulmonary hypertension (PH) centers throughout the U.S. The development of a national USPHSR Registry will be an important element for advancement of the understanding of PAH and improvement of the care of patients who suffer from this life threatening disorder.

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. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria

Prior to enrollment in the Registry, candidates must meet the following inclusion criteria:

  • Diagnosis of WHO Group I PAH (< 6 months) including the following subgroups:

1. Pulmonary Arterial Hypertension (PAH)

  1. Idiopathic PAH
  2. Heritable PAH
    1. ALK-1, ENG,SMAD9CAV1KCNK3
    2. Drug and toxin induced Associated With:
      1. Connective tissue disease
      2. HIV infection
      3. Portal hypertension
      4. Congenital systemic to pulmonary shunts
     1’ Pulmonary veno-occlusive disease and/or pulmonary capillary hemangiomatosis
    • Documentation of the following hemodynamic parameters by pulmonary artery Catheterization
    • Mean pulmonary arterial pressure (PAPm) ≥ 25 mm Hg at rest and,
    • Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) ≤ 15 mm Hg in the absence of mitral stenosis and,
    • Pulmonary vascular resistance (PVR) > 3 Wood Units  
    • Patient has consented to participate in the NHLBI sponsored R24HL105333 National Biological Sample and Data Repository for PAH  
    •  
    •  Exclusion Criteria
                Patients not eligible for enrollment include:
    • Patients unwilling or unable to provide written consent for participation in the study.
    • Patients with an underlying medical disorder (e.g. metastatic cancer) with an anticipated life expectancy less than 2 years.
    • Patients who do not meet inclusion criteria including:
      • Have not had documentation of hemodynamic criteria by pulmonary artery catheterization as outlined in the inclusion criteria
      • Meet the criteria for inclusion into WHO Diagnostic Groups II, III, IV or V

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Robert Frantz, M.D.

Open for enrollment

Contact information:

Lisa Block

(507)538-7297

Block.Lisa@mayo.edu

.
CLS-20304712

Mayo Clinic Footer