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Sponsored by: |
Actelion |
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Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00370214 |
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 |
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Pulmonary Hypertension |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management |
Estimated Enrollment: | 3500 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2012 |
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:
Ages Eligible for Study: | 3 Months and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients with WHO Group I Pulmonary Arterial Hypertension from US based PAH centers.
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathy Feldkircher, PhD. | 650-243-2345 | kathleen.feldkircher@actelion.com |
Contact: Prieya Wason, CCRP | 1-877-738-3255 | info@REVEALregistry.com |
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 |
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 |
Pulmonary arterial hypertension Lung diseases Heart diseases Pulmonary circulation |
Vascular resistance PAH Hypertension |
Heart Diseases Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Idiopathic Pulmonary Hypertension Vascular Diseases Hypertension |
Respiratory Tract Diseases Hypertension, Pulmonary Lung Diseases |
Vascular Diseases Cardiovascular Diseases Hypertension |