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

May 16, 2013 updated by: 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.

Study Overview

Status

Completed

Conditions

Detailed 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

Study Type

Observational

Enrollment (Actual)

3515

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Medical Center
    • California
      • La Jolla, California, United States, 92037
        • University of California, San Diego
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
      • Los Angeles, California, United States, 90073
        • UCLA / VA Medical Center
      • San Francisco, California, United States, 94143
        • Univeristy of California, San Francisco - Division of Cardiology and Pediatric ICU
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
      • Torrance, California, United States, 90502
        • UCLA School of Medicine: Harbor-UCLA
    • Colorado
      • Denver, Colorado, United States, 80218
        • The Children's Hospital
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Sarasota, Florida, United States, 34233
        • Suncoast Lung Center
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Hospitals
      • Naperville, Illinois, United States, 60566
        • Midwest Heart Foundation
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Health Care
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentucky Pulmonary Associates
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine
      • Boston, Massachusetts, United States, 02111
        • Tufts-New England Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
      • Grand Rapids, Michigan, United States, 49506
        • Spectrum Health Hospitals
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Medical Center
      • Rochester, Minnesota, United States, 55095
        • Mayo Clinic
    • Missouri
      • St. Louis, Missouri, United States, 63021
        • Washington University School of Medicine
    • New York
      • Manhasset, New York, United States, 11030
        • North Shore University Hospital
      • New York, New York, United States, 10032
        • Columbia University
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospital of Cleveland
      • Cleveland, Ohio, United States, 44022
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University
      • Columbus, Ohio, United States, 43210
        • Children's Hospital
    • Oregon
      • Portland, Oregon, United States, 97210
        • Legacy Pulmonary Hypertension Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple Lung Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medial Center
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt Children's Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital
      • San Antonio, Texas, United States, 78229
        • University Texas Health Science Center
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Heart and Vascular Institute
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Aurora St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with WHO Group I Pulmonary Arterial Hypertension from US based PAH centers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
clinical predictors, precise outcome definitions
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Chair: Michael D. McGoon, M.D., Mayo Clinic - Rochester, Minnesota
  • Study Director: David B. Badesch, M.D., University of Colorado, Denver
  • Study Director: Robyn J. Barst, M.D., Columbia University
  • Study Director: Raymond Benza, M.D., University of Alabama at Birmingham
  • Study Director: Gregory Elliott, M.D., LDS Hospital
  • Study Director: Harrison Farber, M.D., Boston Medical Center
  • Study Director: Adaani Frost, M.D., Baylor College of Medicine
  • Study Director: Abby Krichman, RRT, Duke University Pulmonary Vascular Disease Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 29, 2006

First Submitted That Met QC Criteria

August 29, 2006

First Posted (Estimate)

August 31, 2006

Study Record Updates

Last Update Posted (Estimate)

May 17, 2013

Last Update Submitted That Met QC Criteria

May 16, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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