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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00370214
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : May 17, 2013
Sponsor:
Information provided by (Responsible Party):
Actelion

Tracking Information
First Submitted Date August 29, 2006
First Posted Date August 31, 2006
Last Update Posted Date May 17, 2013
Study Start Date March 2006
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2013)		 Survival [ Time Frame: 5 years ]
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: May 16, 2013)		 clinical predictors, precise outcome definitions [ Time Frame: 5 years ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
Official Title REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
Brief 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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with WHO Group I Pulmonary Arterial Hypertension from US based PAH centers.
Condition Pulmonary Hypertension
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 16, 2013)		 3515
Original Enrollment
 (submitted: August 29, 2006)		 3000
Actual Study Completion Date December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 3 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00370214
Other Study ID Numbers CR001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Actelion
Original Responsible Party Not Provided
Current Study Sponsor Actelion
Original Study Sponsor CoTherix
Collaborators Not Provided
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
PRS Account Actelion
Verification Date May 2013