Clinical trial NCT04071327: Pulmonary Hypertension Association Registry
Official title: Pulmonary Hypertension Association Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Arterial Hypertension
Chronic Thromboembolic Pulmonary Hypertension
Pulmonary Hypertension
Lead sponsor: Pulmonary Hypertension Association, Inc.
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Proportion of PAH and CTEPH patients completing all guideline-recommended diagnostics
timeFrame: 10 years
measure: Impact of clinical predictors of disease worsening on patient outcomes
timeFrame: 10 years
measure: Survival
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists, Ltd.
state: Arizona
city: Sacramento
country: United States
facility: UC Davis Health
state: California
city: San Francisco
country: United States
facility: UCSF Medical Center
state: California
city: San Francisco
country: United States
facility: UCSF Benioff Children's Hospital
state: California
city: Santa Barbara
country: United States
facility: Cottage Health System - Santa Barbara Pulmonary Associates
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Aurora
country: United States
facility: UC Health - Anschutz Medical Campus
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Health
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinic
state: Iowa
city: Kansas City
country: United States
facility: KU Medical Center
state: Kansas
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Jefferson
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: New Orleans
country: United States
facility: LSU Healthcare Network Clinic
state: Louisiana
city: Baltimore
country: United States
facility: University of MD Medical Group, PA
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Minneapolis
country: United States
facility: University of Minnesota Health
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center/NewYork-Presbyterian Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: UNC Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Cincinnati
country: United States
facility: UC Health
state: Ohio
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Knoxville
country: United States
facility: Ft. Sanders Regional Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Plano
country: United States
facility: Baylor Scott & White
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Norfolk
country: United States
facility: Sentara Heart Hospital
state: Virginia
city: Richmond
country: United States
facility: VCU Medical Center
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert & Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
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citation: Hemnes AR, Leopold JA, Radeva MK, Beck GJ, Abidov A, Aldred MA, Barnard J, Rosenzweig EB, Borlaug BA, Chung WK, Comhair SAA, Desai AA, Dubrock HM, Erzurum SC, Finet JE, Frantz RP, Garcia JGN, Geraci MW, Gray MP, Grunig G, Hassoun PM, Highland KB, Hill NS, Hu B, Kwon DH, Jacob MS, Jellis CL, Larive AB, Lempel JK, Maron BA, Mathai SC, McCarthy K, Mehra R, Nawabit R, Newman JH, Olman MA, Park MM, Ramos JA, Renapurkar RD, Rischard FP, Sherer SG, Tang WHW, Thomas JD, Vanderpool RR, Waxman AB, Wilcox JD, Yuan JX, Horn EM; PVDOMICS Study Group. Clinical Characteristics and Transplant-Free Survival Across the Spectrum of Pulmonary Vascular Disease. J Am Coll Cardiol. 2022 Aug 16;80(7):697-718. doi: 10.1016/j.jacc.2022.05.038.
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citation: Simpson CE, Hemnes AR, Griffiths M, Grunig G, Tang WHW, Garcia JGN, Barnard J, Comhair SA, Damico RL, Mathai SC, Hassoun PM; PVDOMICS Study Group. Metabolomic Differences in Connective Tissue Disease-Associated Versus Idiopathic Pulmonary Arterial Hypertension in the PVDOMICS Cohort. Arthritis Rheumatol. 2023 Dec;75(12):2240-2251. doi: 10.1002/art.42632. Epub 2023 Oct 30.
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citation: Rischard FP, Bernardo RJ, Vanderpool RR, Kwon DH, Acharya T, Park MM, Katrynuik A, Insel M, Kubba S, Badagliacca R, Larive AB, Naeije R, Garcia JGN, Beck GJ, Erzurum SC, Frantz RP, Hassoun PM, Hemnes AR, Hill NS, Horn EM, Leopold JA, Rosenzweig EB, Tang WHW, Wilcox JD. Classification and Predictors of Right Ventricular Functional Recovery in Pulmonary Arterial Hypertension. Circ Heart Fail. 2023 Oct;16(10):e010555. doi: 10.1161/CIRCHEARTFAILURE.123.010555. Epub 2023 Sep 4.