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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT00370214
First received: August 29, 2006
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition
Pulmonary Hypertension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • clinical predictors, precise outcome definitions [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 3515
Study Start Date: March 2006
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   3 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00370214

  Show 54 Study Locations
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided by Actelion

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT00370214     History of Changes
Other Study ID Numbers: CR001
Study First Received: August 29, 2006
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Actelion:
Pulmonary arterial hypertension
Lung diseases
Heart diseases
Pulmonary circulation
Vascular resistance
PAH
Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014