REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management
- Conditions
- Pulmonary Hypertension
- Registration Number
- NCT00370214
- Lead Sponsor
- Actelion
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3515
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Survival 5 years
- Secondary Outcome Measures
Name Time Method clinical predictors, precise outcome definitions 5 years
Trial Locations
- Locations (53)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of Arizona Medical Center
🇺🇸Tucson, Arizona, United States
University of California, San Diego
🇺🇸La Jolla, California, United States
UCLA / VA Medical Center
🇺🇸Los Angeles, California, United States
UCLA Medical Center
🇺🇸Los Angeles, California, United States
Univeristy of California, San Francisco - Division of Cardiology and Pediatric ICU
🇺🇸San Francisco, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
UCLA School of Medicine: Harbor-UCLA
🇺🇸Torrance, California, United States
The Children's Hospital
🇺🇸Denver, Colorado, United States
University of Colorado Health Sciences Center
🇺🇸Denver, Colorado, United States
Scroll for more (43 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States