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Recruiting NCT04071327

Pulmonary Hypertension Association Registry

— Observational Pulmonary Arterial Hypertension Chronic Thromboembolic Pulmonary Hypertension Pulmonary Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pulmonary Arterial Hypertension, Chronic Thromboembolic Pulmonary Hypertension, Pulmonary Hypertension. Basic parameters: from 0 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Proportion of PAH and CTEPH patients completing all guideline-recommended diagnostics [Time frame: 10 years]
  • Impact of clinical predictors of disease worsening on patient outcomes [Time frame: 10 years]
  • Survival [Time frame: 10 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 52 centers
  • Arizona Pulmonary Specialists, Ltd. — Phoenix
  • UC Davis Health — Sacramento
  • UCSF Medical Center — San Francisco
  • UCSF Benioff Children's Hospital — San Francisco
  • Cottage Health System - Santa Barbara Pulmonary Associates — Santa Barbara
  • Stanford University — Stanford
  • Children's Hospital Colorado — Aurora
  • UC Health - Anschutz Medical Campus — Aurora
  • … and 44 more centers

Publications

  • 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 Pulmo PMID 29074534
  • 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: 10.11 PMID 32088984
  • 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 Cardiov PMID 34097027
  • 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, Ram PMID 35953136
  • 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. PMID 36618713
  • 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. PMID 36879444
  • 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. PMID 37335853
  • 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):e PMID 37614830

Identifiers

NCT: NCT04071327 · PHAR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗