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REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
This study is currently recruiting participants.
Verified by Actelion, August 2009
First Received: August 29, 2006   Last Updated: August 4, 2009   History of Changes
Sponsored by: Actelion
Information provided by: Actelion
ClinicalTrials.gov Identifier: NCT00370214
  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: Cohort, 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:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 3500
Study Start Date: March 2006
Estimated Study Completion Date: December 2012
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

Contacts
Contact: Kathy Feldkircher, PhD. 650-243-2345 kathleen.feldkircher@actelion.com
Contact: Prieya Wason, CCRP 1-877-738-3255 info@REVEALregistry.com

  Show 55 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 at Denver and Health Sciences Center
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

Responsible Party: Senior Vice President, Medical ( Kirk Taylor, MD )
Study ID Numbers: CR001
Study First Received: August 29, 2006
Last Updated: August 4, 2009
ClinicalTrials.gov Identifier: NCT00370214     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Heart Diseases
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Idiopathic Pulmonary Hypertension
Vascular Diseases
Hypertension

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

ClinicalTrials.gov processed this record on September 09, 2009