Pulmonary Hypertension Association Registry

Pulmonary Hypertension Clinical Trial

— PHAR  

Official title:

Pulmonary Hypertension Association Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071327
• Other study ID #: PHAR
• Status: Recruiting
• Start date: October 2015
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Pulmonary Hypertension Association, Inc.
• Contact: Elizabeth Joseloff, PhD
• Phone: 301-565-3004
• Email: PHAR[@]PHAssociation.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Thromboembolic Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Arterial Hypertension
• Pulmonary Hypertension

Locations

Country	Name	City	State
United States	AnMed Health	Anderson	South Carolina
United States	Northside Hospital	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	UC Health - Anschutz Medical Campus	Aurora	Colorado
United States	Johns Hopkins University	Baltimore	Maryland
United States	University of MD Medical Group, PA	Baltimore	Maryland
United States	UNC Chapel Hill	Chapel Hill	North Carolina
United States	University of Virginia	Charlottesville	Virginia
United States	Cincinnati Children's Hospital	Cincinnati	Ohio
United States	UC Health	Cincinnati	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Connecticut Health	Farmington	Connecticut
United States	Texas Children's Hospital	Houston	Texas
United States	Indiana University Health	Indianapolis	Indiana
United States	University of Iowa Hospitals & Clinic	Iowa City	Iowa
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Ochsner Medical Center	Jefferson	Louisiana
United States	KU Medical Center	Kansas City	Kansas
United States	Ft. Sanders Regional Medical Center	Knoxville	Tennessee
United States	Kentuckiana Pulmonary Associates	Louisville	Kentucky
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	Froedtert & Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota Health	Minneapolis	Minnesota
United States	Vanderbilt Children's Hospital	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	LSU Healthcare Network Clinic	New Orleans	Louisiana
United States	Columbia University Medical Center/NewYork-Presbyterian Hospital	New York	New York
United States	Weill Cornell Medical Center	New York	New York
United States	Sentara Heart Hospital	Norfolk	Virginia
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Pulmonary Specialists, Ltd.	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Baylor Scott & White	Plano	Texas
United States	The Oregon Clinic	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	VCU Medical Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	UC Davis Health	Sacramento	California
United States	Washington University in St. Louis	Saint Louis	Missouri
United States	University of Utah Health	Salt Lake City	Utah
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	UCSF Medical Center	San Francisco	California
United States	Cottage Health System - Santa Barbara Pulmonary Associates	Santa Barbara	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Pulmonary Hypertension Association, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (11)

Frantz RP, Leopold JA, Hassoun PM, Hemnes AR, Horn EM, Mathai SC, Rischard FP, Larive AB, Tang WHW, Park MM, Hill NS, Rosenzweig EB. Acute vasoreactivity testing during right heart catheterization in chronic thromboembolic pulmonary hypertension: Results — View Citation

Hemnes AR, Beck GJ, Newman JH, Abidov A, Aldred MA, Barnard J, Berman Rosenzweig E, Borlaug BA, Chung WK, Comhair SAA, Erzurum SC, Frantz RP, Gray MP, Grunig G, Hassoun PM, Hill NS, Horn EM, Hu B, Lempel JK, Maron BA, Mathai SC, Olman MA, Rischard FP, Sys — View 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, — View Citation

Jellis CL, Park MM, Abidov A, Borlaug BA, Brittain EL, Frantz R, Hassoun PM, Horn EM, Jaber WA, Jiwon K, Karas MG, Kwon D, Leopold JA, Maron B, Mathai SC, Mehra R, Rischard F, Rosenzweig EB, Tang WHW, Vanderpool R, Thomas JD; PVDOMICS Study Group. Compreh — View Citation

Lowery MM, Hill NS, Wang L, Rosenzweig EB, Bhat A, Erzurum S, Finet JE, Jellis CL, Kaur S, Kwon DH, Nawabit R, Radeva M, Beck GJ, Frantz RP, Hassoun PM, Hemnes AR, Horn EM, Leopold JA, Rischard FP, Mehra R; Pulmonary Vascular Disease Phenomics (PVDOMICS) — View Citation

Martens P, Yu S, Larive B, Borlaug BA, Erzurum SC, Farha S, Finet JE, Grunig G, Hemnes AR, Hill NS, Horn EM, Jacob M, Kwon DH, Park MM, Rischard FP, Rosenzweig EB, Wilcox JD, Tang WHW; PVDOMICS Study Group. Iron deficiency in pulmonary vascular disease: p — View Citation

Naranjo M, Rosenzweig EB, Hemnes AR, Jacob M, Desai A, Hill NS, Larive AB, Finet JE, Leopold J, Horn E, Frantz R, Rischard F, Erzurum S, Beck G, Mathai SC, Hassoun PM; PVDOMICS Study Group. Frequency of acute vasodilator response (AVR) in incident and pre — View 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 W — View Citation

Simpson CE, Ambade AS, Harlan R, Roux A, Aja S, Graham D, Shah AA, Hummers LK, Hemnes AR, Leopold JA, Horn EM, Berman-Rosenzweig ES, Grunig G, Aldred MA, Barnard J, Comhair SAA, Tang WHW, Griffiths M, Rischard F, Frantz RP, Erzurum SC, Beck GJ, Hill NS, M — View 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 Hyperte — View Citation

Tang WHW, Wilcox JD, Jacob MS, Rosenzweig EB, Borlaug BA, Frantz RP, Hassoun PM, Hemnes AR, Hill NS, Horn EM, Singh HS, Systrom DM, Tedford RJ, Vanderpool RR, Waxman AB, Xiao L, Leopold JA, Rischard FP. Comprehensive Diagnostic Evaluation of Cardiovascula — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of PAH and CTEPH patients completing all guideline-recommended diagnostics	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"	10 years
Primary	Impact of clinical predictors of disease worsening on patient outcomes	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.	10 years
Primary	Survival		10 years

External Links

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