Status:
COMPLETED
REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
Lead Sponsor:
Actelion
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
3+ years
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 patie...
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 strid...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
3515 Patients enrolled
Trial Details
Trial ID
NCT00370214
Start Date
March 1 2006
End Date
December 1 2012
Last Update
May 17 2013
Active Locations (54)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
University of Arizona Medical Center
Tucson, Arizona, United States, 85724
3
University of California, San Diego
La Jolla, California, United States, 92037
4
UCLA / VA Medical Center
Los Angeles, California, United States, 90073