Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00370214
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2006-08-29
Brief Title:
REVEAL Registry Registry to Evaluate Early And Long-term PAH Disease Management
Sponsor:
Actelion
Organization:
Actelion
Study Overview
Official Title:
REVEAL Registry Registry to Evaluate Early And Long-term PAH Disease Management
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The REVEAL Registry is a multicenter observational US-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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None