Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00206856
Status:
TERMINATED
Last Update Posted:
2013-07-29
First Post:
2005-09-13
Brief Title:
Rapid Assessment of Bedside BNP In Treatment of Heart Failure RABBIT
Sponsor:
Abbott RDx Cardiometabolic
Organization:
Abbott RDx Cardiometabolic
Study Overview
Official Title:
Rapid Assessment of Bedside BNP In Treatment of Heart Failure RABBIT
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To determine the clinical utility of using the Triage BNP Test to guide therapy in outpatients with heart failure
Detailed Description:
The Triage BNP Test has been cleared by the US Food and Drug Administration as an aid in the diagnosis and assessment of severity of heart failure In addition to numerous reports describing the diagnostic and prognostic utility of BNP reports from various pilot studies have described decreases in BNP in association with various heart failure therapies Other reports have described modest increases in BNP in association with digitalis and beta-receptor antagonism The observation that the circulating BNP concentration decreases during heart failure therapy coupled with the ability of BNP to be used as a prognostic tool and assess the severity of heart failure it is hypothesized that using BNP measurements to guide heart failure therapy could have a significant impact on the care of heart failure patients This hypothesis is supported by various reports of pilot studies that describe a significant benefit of administering therapy tailored to concentrations of BNP and related peptides Patients that are discharged after a hospitalization for heart failure will be approached for study enrollmentThis is a multi-center single patient-blinded cluster-randomized study Half of the sites will have BNP measurements available to guide therapy experimental arm and the other half of the sites will not have BNP measurements available control arm Blood plasma will be collected at each visit and appropriate forms completed Patients will be asked to complete a Minnesota living with heart failure questionnaire and to do a 6-minute walk test Patients will be followed for 12 months
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