REVEAL Registry™: Registry to Evaluate Early And Long-term PAH Disease Management

Completed

Conditions studied: Pulmonary Hypertension

In brief

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.

Key facts

Study ID

NCT00370214

Run by

Actelion

People needed

3515

Starts

2006-03-01

Expected to finish

2012-12-01

Last updated by the study team

2013-05-17

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• 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
• University of Florida — Gainesville, Florida, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Suncoast Lung Center — Sarasota, Florida, United States
• Medical College of Georgia — Augusta, Georgia, United States
• University of Chicago Hospitals — Chicago, Illinois, United States
• Midwest Heart Foundation — Naperville, Illinois, United States
• University of Iowa Health Care — Iowa City, Iowa, United States
• Kentucky Pulmonary Associates — Louisville, Kentucky, United States
• University of Maryland — Baltimore, Maryland, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Tufts-New England Medical Center — Boston, Massachusetts, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Boston University School of Medicine — Boston, Massachusetts, United States
• Wayne State University — Detroit, Michigan, United States
• Spectrum Health Hospitals — Grand Rapids, Michigan, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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