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
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||3000 participants|
|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|
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.
- 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"
- 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.
- Survival [ Time Frame: 10 years ]
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
|Contact: Elizabeth Joseloff, PhD||301-565-3004 ext 759||PHAR@PHAssociation.org|
|Study Chair:||Daniel Grinnan, MD||Virginia Commonwealth University|