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

Pulmonary Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370214
• Other study ID #: CR001
• Status: Completed
• Phase: N/A
• First received: August 29, 2006
• Last updated: May 16, 2013
• Start date: March 2006
• Est. completion date: December 2012

Study information

• Verified date: May 2013
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3515
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	Johns Hopkins	Baltimore	Maryland
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Boston University School of Medicine	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts-New England Medical Center	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Chicago Hospitals	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospital of Cleveland	Cleveland	Ohio
United States	Children's Hospital	Columbus	Ohio
United States	Ohio State University	Columbus	Ohio
United States	The Children's Hospital	Denver	Colorado
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Wayne State University	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Inova Heart and Vascular Institute	Falls Church	Virginia
United States	University of Florida	Gainesville	Florida
United States	Spectrum Health Hospitals	Grand Rapids	Michigan
United States	Baylor College of Medicine	Houston	Texas
United States	Texas Children's Hospital	Houston	Texas
United States	University of Iowa Health Care	Iowa City	Iowa
United States	Mayo Clinic	Jacksonville	Florida
United States	University of California, San Diego	La Jolla	California
United States	UCLA / VA Medical Center	Los Angeles	California
United States	UCLA Medical Center	Los Angeles	California
United States	Kentucky Pulmonary Associates	Louisville	Kentucky
United States	North Shore University Hospital	Manhasset	New York
United States	Aurora St. Luke's Medical Center	Milwaukee	Wisconsin
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Intermountain Medical Center	Murray	Utah
United States	Midwest Heart Foundation	Naperville	Illinois
United States	Vanderbilt Children's Hospital	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Beth Israel Medical Center	New York	New York
United States	Columbia University	New York	New York
United States	Penn Presbyterian Medial Center	Philadelphia	Pennsylvania
United States	Temple Lung Center	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Legacy Pulmonary Hypertension Clinic	Portland	Oregon
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	University Texas Health Science Center	San Antonio	Texas
United States	Univeristy of California, San Francisco - Division of Cardiology and Pediatric ICU	San Francisco	California
United States	Suncoast Lung Center	Sarasota	Florida
United States	Seattle Children's	Seattle	Washington
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Stanford University Medical Center	Stanford	California
United States	UCLA School of Medicine: Harbor-UCLA	Torrance	California
United States	University of Arizona Medical Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival		5 years	No
Secondary	clinical predictors, precise outcome definitions		5 years	No

External Links

•   Official REVEAL Registry website
•   PAH clinical studies at Mayo Clinic