REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management

Last updated: May 16, 2013
Sponsor: Actelion
Overall Status: Completed

Phase

N/A

Condition

Pulmonary Arterial Hypertension

Diabetes And Hypertension

Circulation Disorders

Treatment

N/A

Clinical Study ID

NCT00370214
CR001
  • Ages > 3
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 withexercise 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

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 heartcatheterization at some time preceding study entry and following development ofsymptoms associated with PAH.

  • Do not meet the required hemodynamic criteria for entry into the study

Study Design

Total Participants: 3515
Study Start date:
March 01, 2006
Estimated Completion Date:
December 31, 2012

Study Description

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

Connect with a study center

  • University of Alabama at Birmingham

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • University of Arizona Medical Center

    Tucson, Arizona 85724
    United States

    Site Not Available

  • University of California, San Diego

    La Jolla, California 92037
    United States

    Site Not Available

  • UCLA / VA Medical Center

    Los Angeles, California 90073
    United States

    Site Not Available

  • UCLA Medical Center

    Los Angeles, California 90095
    United States

    Site Not Available

  • Univeristy of California, San Francisco - Division of Cardiology and Pediatric ICU

    San Francisco, California 94143
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305
    United States

    Site Not Available

  • UCLA School of Medicine: Harbor-UCLA

    Torrance, California 90502
    United States

    Site Not Available

  • The Children's Hospital

    Denver, Colorado 80218
    United States

    Site Not Available

  • University of Colorado Health Sciences Center

    Denver, Colorado 80262
    United States

    Site Not Available

  • University of Florida

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Mayo Clinic

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Suncoast Lung Center

    Sarasota, Florida 34233
    United States

    Site Not Available

  • Medical College of Georgia

    Augusta, Georgia 30912
    United States

    Site Not Available

  • University of Chicago Hospitals

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Midwest Heart Foundation

    Naperville, Illinois 60566
    United States

    Site Not Available

  • University of Iowa Health Care

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Kentucky Pulmonary Associates

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Johns Hopkins

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • University of Maryland

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Boston University School of Medicine

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts-New England Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Wayne State University

    Detroit, Michigan 48201
    United States

    Site Not Available

  • Spectrum Health Hospitals

    Grand Rapids, Michigan 49506
    United States

    Site Not Available

  • University of Minnesota Medical Center

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55095
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63021
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Beth Israel Medical Center

    New York, New York 10003
    United States

    Site Not Available

  • Columbia University

    New York, New York 10032
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Cleveland Clinic Foundation

    Cleveland, Ohio 44022
    United States

    Site Not Available

  • University Hospital of Cleveland

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Children's Hospital

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Legacy Pulmonary Hypertension Clinic

    Portland, Oregon 97210
    United States

    Site Not Available

  • Penn Presbyterian Medial Center

    Philadelphia, Pennsylvania 19104
    United States

    Site Not Available

  • Temple Lung Center

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Vanderbilt Children's Hospital

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Texas Children's Hospital

    Houston, Texas 77030
    United States

    Site Not Available

  • University Texas Health Science Center

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Site Not Available

  • Inova Heart and Vascular Institute

    Falls Church, Virginia 22042
    United States

    Site Not Available

  • Virginia Commonwealth University

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Seattle Children's

    Seattle, Washington 98105
    United States

    Site Not Available

  • Aurora St. Luke's Medical Center

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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