Conference: 2008 International PHA Conference and Scientific Sessions
Release Date: 06.20.2008
Presentation Type: Abstracts
McGoon M.D.1, Badesch D.B.2, Barst R.J.3, Benza R.L.4, Elliott C.G.5, Farber H.6, Frost A.E.7, Krichman A.8, Liou T.G.9, Raskob G.E.10, Giles S.11, Feldkircher K.11, Miller D.P.12
1. Mayo Clinic, Rochester, MN, USA
2. University of Colorado and Health Sciences Center, Denver, CO, USA
3. Columbia University Medical Center, New York, NY, USA
4. University of Alabama at Birmingham, Birmingham, AL, USA
5. LDS Hospital, Salt Lake City, UT, USA
6. Boston University School of Medicine, Boston, MA, USA
7. Baylor College of Medicine, Houston, TX, USA
8. Duke University Medical Center, Durham, NC, USA
9. University of Utah, Salt Lake City, UT, USA
10. University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA
11. Actelion Pharmaceuticals US, Inc., USA
12. ICON Clinical Research, USA
BACKGROUND: There is a need for current and reliable information about the clinical course and management of pulmonary arterial hypertension (PAH). The REVEAL Registry (Registry to EValuate Early And Long-term PAH Disease Management) is a multicenter, observational, U.S.-based study that is designed to meet this need. The objectives of the registry are to characterize the demographics and clinical course of patients diagnosed with WHO Group I PAH and to compare differences in patient outcomes for various subgroups of patients.
METHODS: Approximately 3,000 patients are being enrolled at about 50 sites over the course of approximately two years. All consecutive consenting patients with WHO Group I PAH diagnosed according to specific hemodynamic criteria, including mean PAP > to 25 mm Hg at rest or > 30 mm Hg with exercise, PVR > 3 Wood Units and PCWP < 18 will be enrolled. Patients will be followed for a minimum of five years from the time of enrollment until death, withdrawal of consent, or end of the study.
RESULTS: Patient enrollment began in March, 2006. The following are documented at baseline: date of birth, gender, race, vital signs (blood pressure, heart rate, weight, height), chest X-ray and electrocardiogram results, results of specific laboratory testing, employment status, level of independent function and living situation (i.e. independent, assisted, etc.), major co-morbidities, and current PAH medications including route of administration and dosage. Patient outcomes evaluated include the following: modified NYHA/WHO functional class, 6-minute walk distance, change in pulmonary function test results and in hemodynamic measurements, functional status, and occurrence of hospitalizations or death.
CONCLUSIONS: The REVEAL Registry is the world’s largest registry of its kind, and is designed to bridge the gap between science and practice by characterizing the current management and clinical features of patients with PAH.