Pulmonary Hypertension Clinical Trial
— PHAROfficial title:
Pulmonary Hypertension Association Registry
| NCT number | NCT04071327 |
| Other study ID # | PHAR |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | October 2015 |
| Est. completion date | October 2025 |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Pulmonary Hypertension Association, Inc. |
United States,
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 from the pulmonary vascular disease phenomics study. Pulm Circ. 2023 Jan 6;13(1):e12181. doi: 10.1002/pul2.12181. eCollection 2023 Jan. — 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, Systrom DM, Tang WHW, Waxman AB, Xiao L, Yuan JX, Leopold JA; PVDOMICS Study Group. PVDOMICS: A Multi-Center Study to Improve Understanding of Pulmonary Vascular Disease Through Phenomics. Circ Res. 2017 Oct 27;121(10):1136-1139. doi: 10.1161/CIRCRESAHA.117.311737. — 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, 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. — 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. Comprehensive echocardiographic evaluation of the right heart in patients with pulmonary vascular diseases: the PVDOMICS experience. Eur Heart J Cardiovasc Imaging. 2022 Jun 21;23(7):958-969. doi: 10.1093/ehjci/jeab065. — 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) Study Group. Sleep-Related Hypoxia, Right Ventricular Dysfunction, and Survival in Patients With Group 1 Pulmonary Arterial Hypertension. J Am Coll Cardiol. 2023 Nov 21;82(21):1989-2005. doi: 10.1016/j.jacc.2023.09.806. — 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: pathophysiological and clinical implications. Eur Heart J. 2023 Jun 9;44(22):1979-1991. doi: 10.1093/eurheartj/ehad149. — 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 prevalent patients with pulmonary arterial hypertension: Results from the pulmonary vascular disease phenomics study. Pulm Circ. 2023 Aug 21;13(3):e12281. doi: 10.1002/pul2.12281. eCollection 2023 Jul. — 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 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. — 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, Mathai SC, Hassoun PM, Damico RL; the PVDOMICS Study Group. Kynurenine pathway metabolism evolves with development of preclinical and scleroderma-associated pulmonary arterial hypertension. Am J Physiol Lung Cell Mol Physiol. 2023 Nov 1;325(5):L617-L627. doi: 10.1152/ajplung.00177.2023. Epub 2023 Oct 3. — 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 Hypertension in the PVDOMICS Cohort. Arthritis Rheumatol. 2023 Dec;75(12):2240-2251. doi: 10.1002/art.42632. Epub 2023 Oct 30. — 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 Cardiovascular Physiology in Patients With Pulmonary Vascular Disease: Insights From the PVDOMICS Program. Circ Heart Fail. 2020 Mar;13(3):e006363. doi: 10.1161/CIRCHEARTFAILURE.119.006363. Epub 2020 Feb 24. — View Citation
* Note: There are 11 references in all — Click here to view all references
| 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 |
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