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PHAR: Pulmonary Hypertension Association Registry

Sponsor
Pulmonary Hypertension Association, Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT04071327
Collaborator
University of Washington, the Collaborative Health Studies Coordinating Center (Other)
3,000
Enrollment
52
Locations
120
Anticipated Duration (Months)
57.7
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The PHA Registry (PHAR) is a national study about people who have pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). PHAR collects information from people with PAH and CTEPH who are cared for in participating PHA-accredited Pulmonary Hypertension Care Centers throughout the U.S.

PHAR will determine how people with PAH and CTEPH are evaluated, tested, and treated, and will observe how well these participants do. The goal is to see if people with PH are treated according to recommended guidelines, and to see if there are certain factors that can lead to better or worse outcomes.

PHAR will include information about people with PAH and CTEPH in the U.S. who are seen at participating PHA-accredited PH Care Centers. PHAR contains data about patient care and outcomes. Specifically, data in the PHAR includes information on diagnosis; clinical status; socioeconomic status; diagnosis test results; body size; treatment information; interest in participating in clinical trials; family health and social history; and information about smoking, alcohol, or drug use. Participants are followed over time, and provide updates such as changes in therapy, how often participants need to go to the hospital, and survival. Such information may help healthcare providers provide better care.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Pulmonary Hypertension Association Registry
    Actual Study Start Date :
    Oct 1, 2015
    Anticipated Primary Completion Date :
    Oct 1, 2025
    Anticipated Study Completion Date :
    Oct 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Pulmonary arterial hypertension (PAH)

    Patients with newly diagnosed or established PAH, within 6 months of first outpatient visit to a PH Care Center
    Chronic thromboembolic pulmonary hypertension (CTEPH)

    Patients with newly diagnosed or established CTEPH, within 6 months of first outpatient visit to a PH Care Center
    Group 3 PH due to Developmental Lung Disease

    Pediatric patients with newly diagnosed or established Group 3 PH due to developmental lung disease, within 6 months of first outpatient visit to a PH Care Center.

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of PAH and CTEPH patients completing all guideline-recommended diagnostics [10 years]

      PAH guideline-recommended diagnostics assessed include chest radiography, echocardiogram, ventilation-perfusion (V/Q) scan, pulmonary function tests, overnight oximetry, and right heart catheterization and identified as either "completed" or "not completed"

    2. Impact of clinical predictors of disease worsening on patient outcomes [10 years]

      Prognostic importance of disease worsening predictors including changes in World Health Organization (WHO) / New York Heart Association (NYHA) functional class (I-IV), 6-minute walk distance in meters, and brain natriuretic peptide (BNP) in pg/mL on survival.

    3. Survival [10 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All age groups

    • Written informed consent

    • Pulmonary arterial hypertension (PAH), chronic thromboembolic pulmonary hypertension (CTEPH), or pediatric PH due to developmental lung disease

    • Within 6 months of first outpatient visit at a PH Care Center

    Exclusion Criteria:

    • Diagnosis of WSPH Group 2 pulmonary hypertension

    • Diagnosis of WSPH Group 3 pulmonary hypertension, except PH due to developmental lung disease

    • Diagnosis of WSPH Group 5 pulmonary hypertension

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Pulmonary Specialists, Ltd. Phoenix Arizona United States 85012
    2 UC Davis Health Sacramento California United States 95816
    3 UCSF Medical Center San Francisco California United States 94143
    4 UCSF Benioff Children's Hospital San Francisco California United States 94158
    5 Cottage Health System - Santa Barbara Pulmonary Associates Santa Barbara California United States 93105
    6 Stanford University Stanford California United States 94305
    7 Children's Hospital Colorado Aurora Colorado United States 80045
    8 UC Health - Anschutz Medical Campus Aurora Colorado United States 80045
    9 University of Connecticut Health Farmington Connecticut United States 06030
    10 Mayo Clinic Florida Jacksonville Florida United States 32224
    11 Northside Hospital Atlanta Georgia United States 30342
    12 Indiana University Health Indianapolis Indiana United States 46202
    13 University of Iowa Hospitals & Clinic Iowa City Iowa United States 52242
    14 KU Medical Center Kansas City Kansas United States 66160
    15 Kentuckiana Pulmonary Associates Louisville Kentucky United States 40202
    16 Ochsner Medical Center Jefferson Louisiana United States 70121
    17 LSU Healthcare Network Clinic New Orleans Louisiana United States 70115
    18 University of MD Medical Group, PA Baltimore Maryland United States 21201
    19 Johns Hopkins University Baltimore Maryland United States 21287
    20 Henry Ford Hospital Detroit Michigan United States 48202
    21 University of Minnesota Health Minneapolis Minnesota United States 55455
    22 Mayo Clinic Rochester Minnesota United States 55905
    23 Washington University in St. Louis Saint Louis Missouri United States 63110
    24 Weill Cornell Medical Center New York New York United States 10021
    25 Columbia University Medical Center/NewYork-Presbyterian Hospital New York New York United States 10032
    26 University of Rochester Medical Center Rochester New York United States 14642-0001
    27 UNC Chapel Hill Chapel Hill North Carolina United States 27517
    28 Duke University Medical Center Durham North Carolina United States 27710
    29 Cincinnati Children's Hospital Cincinnati Ohio United States 45229
    30 UC Health Cincinnati Ohio United States 45267
    31 The Oregon Clinic Portland Oregon United States 97225
    32 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    33 Allegheny General Hospital Pittsburgh Pennsylvania United States 15212
    34 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15213
    35 Rhode Island Hospital Providence Rhode Island United States 02903
    36 AnMed Health Anderson South Carolina United States 29621
    37 Ft. Sanders Regional Medical Center Knoxville Tennessee United States 37916
    38 Vanderbilt Children's Hospital Nashville Tennessee United States 37232
    39 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    40 UT Southwestern Medical Center Dallas Texas United States 75390
    41 Texas Children's Hospital Houston Texas United States 77030
    42 Baylor Scott & White Plano Texas United States 75093
    43 University of Utah Health Salt Lake City Utah United States 84132
    44 University of Virginia Charlottesville Virginia United States 22908
    45 Inova Fairfax Hospital Falls Church Virginia United States 22042
    46 Sentara Heart Hospital Norfolk Virginia United States 23507
    47 VCU Medical Center Richmond Virginia United States 23298
    48 Seattle Children's Hospital Seattle Washington United States 98105
    49 University of Washington Seattle Washington United States 98195
    50 University of Wisconsin Hospital and Clinics Madison Wisconsin United States 53792
    51 Aurora St. Luke's Medical Center Milwaukee Wisconsin United States 53215
    52 Froedtert & Medical College of Wisconsin Milwaukee Wisconsin United States 53226

    Sponsors and Collaborators

    • Pulmonary Hypertension Association, Inc.
    • University of Washington, the Collaborative Health Studies Coordinating Center

    Investigators

    • Study Chair: Daniel Grinnan, MD, Virginia Commonwealth University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Pulmonary Hypertension Association, Inc.
    ClinicalTrials.gov Identifier:
    NCT04071327
    Other Study ID Numbers:
    • PHAR
    First Posted:
    Aug 28, 2019
    Last Update Posted:
    Apr 3, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension, Pulmonary
    Pulmonary Arterial Hypertension
    Hypertension

    Study Results

    No Results Posted as of Apr 3, 2020