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Pulmonary Hypertension Association Registry (PHAR)

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ClinicalTrials.gov Identifier: NCT04071327
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
University of Washington, the Collaborative Health Studies Coordinating Center
Information provided by (Responsible Party):
Pulmonary Hypertension Association, Inc.

Study Description
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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
Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension Pulmonary Hypertension

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Pulmonary Hypertension Association Registry
Actual Study Start Date : October 2015
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : October 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Proportion of PAH and CTEPH patients completing all guideline-recommended diagnostics [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 10 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
New patients to a PHA-accredited PH Care Center (PHCC) with either newly diagnosed or established 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 the PHCC.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071327


Contacts
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Contact: Elizabeth Joseloff, PhD 301-565-3004 ext 759 PHAR@PHAssociation.org

Locations
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Sponsors and Collaborators
Pulmonary Hypertension Association, Inc.
University of Washington, the Collaborative Health Studies Coordinating Center
Investigators
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Study Chair: Daniel Grinnan, MD Virginia Commonwealth University
More Information
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Additional Information:

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Responsible Party: Pulmonary Hypertension Association, Inc.
ClinicalTrials.gov Identifier: NCT04071327    
Other Study ID Numbers: PHAR
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Pulmonary Arterial Hypertension
Hypertension
Vascular Diseases
 Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases