REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
16 maja 2013 zaktualizowane przez: Actelion
The REVEAL Registry™ is a multicenter, observational, U.S.-based study of the clinical course and disease management of pulmonary arterial hypertension (PAH) patients.
All consecutive consenting patients diagnosed with WHO Group I PAH according to specific hemodynamic criteria at participating institutions will be enrolled.
Participating patients will be followed for a minimum of five years from the time of enrollment.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
Pulmonary arterial hypertension (PAH) is a chronic, progressive, and often fatal disease characterized by severe constriction of the blood vessels in the lungs. Over the past decade, significant strides have been made in the medical management and understanding of PAH. However, much remains to be learned about the clinical course of both idiopathic PAH and associated PAH, including clinical presentation, pace of progression, key parameters to monitor, impact of treatment, and prognosticators of outcome. As the unique body of knowledge generated by the REVEAL Registry grows, it is hoped that new understandings, insights, and treatments will emerge that will improve the lives of patients with PAH.
The REVEAL Registry will provide investigators with descriptive data regarding the clinical course and treatment outcomes in patients with WHO Group I PAH. Data derived from the study may offer important tools for assessing current management practices of treating investigators, as well as changes over time. Additionally, the relationship of patient- and disease-specific parameters to patient outcomes may be able to be assessed through analysis of data from this study.
The specific objectives of the REVEAL Registry™ are to:
- Characterize the demographics and clinical course of PAH patients
- Evaluate and compare patient outcomes
- Identify clinical predictors of short-term and long-term clinical outcomes
- Assess the relationship between PAH medications and patient outcomes
- Report temporal trends in treatments and outcomes for newly diagnosed patients
- Collect timely and relevant data for the evolving research needs of the PAH community
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
3515
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35294
- University of Alabama at Birmingham
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Arizona
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Tucson, Arizona, Stany Zjednoczone, 85724
- University of Arizona Medical Center
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California
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La Jolla, California, Stany Zjednoczone, 92037
- University of California, San Diego
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Los Angeles, California, Stany Zjednoczone, 90095
- UCLA Medical Center
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Los Angeles, California, Stany Zjednoczone, 90073
- UCLA / VA Medical Center
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San Francisco, California, Stany Zjednoczone, 94143
- Univeristy of California, San Francisco - Division of Cardiology and Pediatric ICU
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Stanford, California, Stany Zjednoczone, 94305
- Stanford University Medical Center
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Torrance, California, Stany Zjednoczone, 90502
- UCLA School of Medicine: Harbor-UCLA
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Colorado
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Denver, Colorado, Stany Zjednoczone, 80218
- The Children's Hospital
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Denver, Colorado, Stany Zjednoczone, 80262
- University of Colorado Health Sciences Center
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Florida
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Gainesville, Florida, Stany Zjednoczone, 32610
- University of Florida
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Jacksonville, Florida, Stany Zjednoczone, 32224
- Mayo Clinic
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Sarasota, Florida, Stany Zjednoczone, 34233
- Suncoast Lung Center
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Georgia
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Augusta, Georgia, Stany Zjednoczone, 30912
- Medical College of Georgia
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Illinois
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Chicago, Illinois, Stany Zjednoczone, 60637
- University of Chicago Hospitals
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Naperville, Illinois, Stany Zjednoczone, 60566
- Midwest Heart Foundation
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Iowa
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Iowa City, Iowa, Stany Zjednoczone, 52242
- University of Iowa Health Care
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Kentucky
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Louisville, Kentucky, Stany Zjednoczone, 40202
- Kentucky Pulmonary Associates
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Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21201
- University of Maryland
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Baltimore, Maryland, Stany Zjednoczone, 21205
- Johns Hopkins
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02114
- Massachusetts General Hospital
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Boston, Massachusetts, Stany Zjednoczone, 02118
- Boston University School of Medicine
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Boston, Massachusetts, Stany Zjednoczone, 02111
- Tufts-New England Medical Center
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Michigan
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Detroit, Michigan, Stany Zjednoczone, 48201
- Wayne State University
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Grand Rapids, Michigan, Stany Zjednoczone, 49506
- Spectrum Health Hospitals
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Minnesota
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Minneapolis, Minnesota, Stany Zjednoczone, 55455
- University of Minnesota Medical Center
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Rochester, Minnesota, Stany Zjednoczone, 55095
- Mayo Clinic
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Missouri
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St. Louis, Missouri, Stany Zjednoczone, 63021
- Washington University School of Medicine
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New York
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Manhasset, New York, Stany Zjednoczone, 11030
- North Shore University Hospital
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New York, New York, Stany Zjednoczone, 10032
- Columbia University
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New York, New York, Stany Zjednoczone, 10003
- Beth Israel Medical Center
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Rochester, New York, Stany Zjednoczone, 14642
- University of Rochester Medical Center
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27710
- Duke University Medical Center
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Ohio
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Cleveland, Ohio, Stany Zjednoczone, 44106
- University Hospital of Cleveland
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Cleveland, Ohio, Stany Zjednoczone, 44022
- Cleveland Clinic Foundation
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Columbus, Ohio, Stany Zjednoczone, 43210
- Ohio State University
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Columbus, Ohio, Stany Zjednoczone, 43210
- Children's Hospital
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Oregon
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Portland, Oregon, Stany Zjednoczone, 97210
- Legacy Pulmonary Hypertension Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19140
- Temple Lung Center
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Penn Presbyterian Medial Center
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15212
- Allegheny General Hospital
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Pittsburgh, Pennsylvania, Stany Zjednoczone, 15213
- University of Pittsburgh Medical Center
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Rhode Island
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Providence, Rhode Island, Stany Zjednoczone, 02903
- Rhode Island Hospital
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South Carolina
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Charleston, South Carolina, Stany Zjednoczone, 29425
- Medical University of South Carolina
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Tennessee
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Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt University Medical Center
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Nashville, Tennessee, Stany Zjednoczone, 37212
- Vanderbilt Children's Hospital
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Texas
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Houston, Texas, Stany Zjednoczone, 77030
- Baylor College of Medicine
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Houston, Texas, Stany Zjednoczone, 77030
- Texas Children's Hospital
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San Antonio, Texas, Stany Zjednoczone, 78229
- University Texas Health Science Center
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Utah
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Murray, Utah, Stany Zjednoczone, 84107
- Intermountain Medical Center
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Virginia
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Falls Church, Virginia, Stany Zjednoczone, 22042
- Inova Heart and Vascular Institute
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Richmond, Virginia, Stany Zjednoczone, 23298
- Virginia Commonwealth University
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Washington
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Seattle, Washington, Stany Zjednoczone, 98105
- Seattle Children's
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Wisconsin
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Milwaukee, Wisconsin, Stany Zjednoczone, 53215
- Aurora St. Luke's Medical Center
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
3 miesiące i starsze (Dziecko, Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka prawdopodobieństwa
Badana populacja
Patients with WHO Group I Pulmonary Arterial Hypertension from US based PAH centers.
Opis
Inclusion Criteria:
- Newly diagnosed or previously diagnosed patients with WHO Group I PAH.
- Documentation of the following hemodynamic parameters by right heart catheterization, performed at any time prior to study enrollment:
- Mean pulmonary arterial pressure (mPAP) >25 mm Hg at rest or mPAP > 30 mm Hg with exercise contemporaneous with a pulmonary wedge pressure ≤ 18 mm Hg
- Pulmonary wedge pressure ≤ 18 mm Hg
- Pulmonary vascular resistance (PVR) ≥ 240 dynes.sec.cm-5 (i.e., ≥ 3.0 Wood units)
Exclusion Criteria:
- Patients who meet the criteria for inclusion into WHO Groups II, III, IV or V
- Have not had documentation of hemodynamic criteria for PAH by right heart catheterization at some time preceding study entry and following development of symptoms associated with PAH.
- Do not meet the required hemodynamic criteria for entry into the study
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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Przetrwanie
Ramy czasowe: 5 lat
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5 lat
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
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clinical predictors, precise outcome definitions
Ramy czasowe: 5 years
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5 years
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Krzesło do nauki: Michael D. McGoon, M.D., Mayo Clinic - Rochester, Minnesota
- Dyrektor Studium: David B. Badesch, M.D., University of Colorado, Denver
- Dyrektor Studium: Robyn J. Barst, M.D., Columbia University
- Dyrektor Studium: Raymond Benza, M.D., University of Alabama at Birmingham
- Dyrektor Studium: Gregory Elliott, M.D., LDS Hospital
- Dyrektor Studium: Harrison Farber, M.D., Boston Medical Center
- Dyrektor Studium: Adaani Frost, M.D., Baylor College of Medicine
- Dyrektor Studium: Abby Krichman, RRT, Duke University Pulmonary Vascular Disease Center
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- Torbicki A, Bacchi M, Delcroix M, Farber HW, Ghofrani HA, Hennessy B, Jansa P, Mehta S, Perchenet L, Pulido T, Rosenberg D, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Wei LJ, Channick R, Benza R. Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005095. doi: 10.1161/CIRCOUTCOMES.118.005095.
- Benza RL, Kanwar MK, Raina A, Scott JV, Zhao CL, Selej M, Elliott CG, Farber HW. Development and Validation of an Abridged Version of the REVEAL 2.0 Risk Score Calculator, REVEAL Lite 2, for Use in Patients With Pulmonary Arterial Hypertension. Chest. 2021 Jan;159(1):337-346. doi: 10.1016/j.chest.2020.08.2069. Epub 2020 Sep 1.
- Benza RL, Gomberg-Maitland M, Elliott CG, Farber HW, Foreman AJ, Frost AE, McGoon MD, Pasta DJ, Selej M, Burger CD, Frantz RP. Predicting Survival in Patients With Pulmonary Arterial Hypertension: The REVEAL Risk Score Calculator 2.0 and Comparison With ESC/ERS-Based Risk Assessment Strategies. Chest. 2019 Aug;156(2):323-337. doi: 10.1016/j.chest.2019.02.004. Epub 2019 Feb 14.
- Preston IR, Roberts KE, Miller DP, Sen GP, Selej M, Benton WW, Hill NS, Farber HW. Effect of Warfarin Treatment on Survival of Patients With Pulmonary Arterial Hypertension (PAH) in the Registry to Evaluate Early and Long-Term PAH Disease Management (REVEAL). Circulation. 2015 Dec 22;132(25):2403-11. doi: 10.1161/CIRCULATIONAHA.115.018435. Epub 2015 Oct 28.
- Farber HW, Miller DP, Poms AD, Badesch DB, Frost AE, Muros-Le Rouzic E, Romero AJ, Benton WW, Elliott CG, McGoon MD, Benza RL. Five-Year outcomes of patients enrolled in the REVEAL Registry. Chest. 2015 Oct;148(4):1043-54. doi: 10.1378/chest.15-0300.
- Chung L, Farber HW, Benza R, Miller DP, Parsons L, Hassoun PM, McGoon M, Nicolls MR, Zamanian RT. Unique predictors of mortality in patients with pulmonary arterial hypertension associated with systemic sclerosis in the REVEAL registry. Chest. 2014 Dec;146(6):1494-1504. doi: 10.1378/chest.13-3014.
- Burger CD, Long PK, Shah MR, McGoon MD, Miller DP, Romero AJ, Benton WW, Safford RE. Characterization of first-time hospitalizations in patients with newly diagnosed pulmonary arterial hypertension in the REVEAL registry. Chest. 2014 Nov;146(5):1263-1273. doi: 10.1378/chest.14-0193.
- Frost AE, Badesch DB, Miller DP, Benza RL, Meltzer LA, McGoon MD. Evaluation of the predictive value of a clinical worsening definition using 2-year outcomes in patients with pulmonary arterial hypertension: a REVEAL Registry analysis. Chest. 2013 Nov;144(5):1521-1529. doi: 10.1378/chest.12-3023.
- Bersohn MM, Turner MP, Traiger GL, Frost AE, Shapiro S. Systemic BP and heart rate as prognostic indicators in pulmonary arterial hypertension. Chest. 2013 Sep;144(3):959-965. doi: 10.1378/chest.12-2572.
- Barst RJ, Chung L, Zamanian RT, Turner M, McGoon MD. Functional class improvement and 3-year survival outcomes in patients with pulmonary arterial hypertension in the REVEAL Registry. Chest. 2013 Jul;144(1):160-168. doi: 10.1378/chest.12-2417.
- Poms AD, Turner M, Farber HW, Meltzer LA, McGoon MD. Comorbid conditions and outcomes in patients with pulmonary arterial hypertension: a REVEAL registry analysis. Chest. 2013 Jul;144(1):169-176. doi: 10.1378/chest.11-3241.
- Kitterman N, Poms A, Miller DP, Lombardi S, Farber HW, Barst RJ. Bloodstream infections in patients with pulmonary arterial hypertension treated with intravenous prostanoids: insights from the REVEAL REGISTRY(R). Mayo Clin Proc. 2012 Sep;87(9):825-34. doi: 10.1016/j.mayocp.2012.05.014. Epub 2012 Aug 9.
- Frost AE, Farber HW, Barst RJ, Miller DP, Elliott CG, McGoon MD. Demographics and outcomes of patients diagnosed with pulmonary hypertension with pulmonary capillary wedge pressures 16 to 18 mm Hg: insights from the REVEAL Registry. Chest. 2013 Jan;143(1):185-195. doi: 10.1378/chest.11-1387.
- Benza RL, Miller DP, Barst RJ, Badesch DB, Frost AE, McGoon MD. An evaluation of long-term survival from time of diagnosis in pulmonary arterial hypertension from the REVEAL Registry. Chest. 2012 Aug;142(2):448-456. doi: 10.1378/chest.11-1460.
- Barst RJ, McGoon MD, Elliott CG, Foreman AJ, Miller DP, Ivy DD. Survival in childhood pulmonary arterial hypertension: insights from the registry to evaluate early and long-term pulmonary arterial hypertension disease management. Circulation. 2012 Jan 3;125(1):113-22. doi: 10.1161/CIRCULATIONAHA.111.026591. Epub 2011 Nov 15.
- Krowka MJ, Miller DP, Barst RJ, Taichman D, Dweik RA, Badesch DB, McGoon MD. Portopulmonary hypertension: a report from the US-based REVEAL Registry. Chest. 2012 Apr;141(4):906-915. doi: 10.1378/chest.11-0160. Epub 2011 Jul 21.
- Shapiro S, Traiger GL, Turner M, McGoon MD, Wason P, Barst RJ. Sex differences in the diagnosis, treatment, and outcome of patients with pulmonary arterial hypertension enrolled in the registry to evaluate early and long-term pulmonary arterial hypertension disease management. Chest. 2012 Feb;141(2):363-373. doi: 10.1378/chest.10-3114. Epub 2011 Jul 14.
- Benza RL, Gomberg-Maitland M, Miller DP, Frost A, Frantz RP, Foreman AJ, Badesch DB, McGoon MD. The REVEAL Registry risk score calculator in patients newly diagnosed with pulmonary arterial hypertension. Chest. 2012 Feb;141(2):354-362. doi: 10.1378/chest.11-0676. Epub 2011 Jun 16.
- Brown LM, Chen H, Halpern S, Taichman D, McGoon MD, Farber HW, Frost AE, Liou TG, Turner M, Feldkircher K, Miller DP, Elliott CG. Delay in recognition of pulmonary arterial hypertension: factors identified from the REVEAL Registry. Chest. 2011 Jul;140(1):19-26. doi: 10.1378/chest.10-1166. Epub 2011 Mar 10.
- Burger CD, Foreman AJ, Miller DP, Safford RE, McGoon MD, Badesch DB. Comparison of body habitus in patients with pulmonary arterial hypertension enrolled in the Registry to Evaluate Early and Long-term PAH Disease Management with normative values from the National Health and Nutrition Examination Survey. Mayo Clin Proc. 2011 Feb;86(2):105-12. doi: 10.4065/mcp.2010.0394.
- Benza RL, Miller DP, Gomberg-Maitland M, Frantz RP, Foreman AJ, Coffey CS, Frost A, Barst RJ, Badesch DB, Elliott CG, Liou TG, McGoon MD. Predicting survival in pulmonary arterial hypertension: insights from the Registry to Evaluate Early and Long-Term Pulmonary Arterial Hypertension Disease Management (REVEAL). Circulation. 2010 Jul 13;122(2):164-72. doi: 10.1161/CIRCULATIONAHA.109.898122. Epub 2010 Jun 28.
- Frost AE, Badesch DB, Barst RJ, Benza RL, Elliott CG, Farber HW, Krichman A, Liou TG, Raskob GE, Wason P, Feldkircher K, Turner M, McGoon MD. The changing picture of patients with pulmonary arterial hypertension in the United States: how REVEAL differs from historic and non-US Contemporary Registries. Chest. 2011 Jan;139(1):128-37. doi: 10.1378/chest.10-0075. Epub 2010 Jun 17. Erratum In: Chest. 2011 Oct;140(4):1106.
- Chung L, Liu J, Parsons L, Hassoun PM, McGoon M, Badesch DB, Miller DP, Nicolls MR, Zamanian RT. Characterization of connective tissue disease-associated pulmonary arterial hypertension from REVEAL: identifying systemic sclerosis as a unique phenotype. Chest. 2010 Dec;138(6):1383-94. doi: 10.1378/chest.10-0260. Epub 2010 May 27.
Przydatne linki
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 marca 2006
Zakończenie podstawowe (Rzeczywisty)
1 grudnia 2012
Ukończenie studiów (Rzeczywisty)
1 grudnia 2012
Daty rejestracji na studia
Pierwszy przesłany
29 sierpnia 2006
Pierwszy przesłany, który spełnia kryteria kontroli jakości
29 sierpnia 2006
Pierwszy wysłany (Oszacować)
31 sierpnia 2006
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
17 maja 2013
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
16 maja 2013
Ostatnia weryfikacja
1 maja 2013
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CR001
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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