Clinical Trials Directory

Trials / Completed

CompletedNCT00370214

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

Status
Completed
Phase
Study type
Observational
Enrollment
3,515 (actual)
Sponsor
Actelion · Industry
Sex
All
Age
3 Months
Healthy volunteers
Not accepted

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

Conditions

Timeline

Start date
2006-03-01
Primary completion
2012-12-01
Completion
2012-12-01
First posted
2006-08-31
Last updated
2013-05-17

Locations

54 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00370214. Inclusion in this directory is not an endorsement.