Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484770
Status:
COMPLETED
Last Update Posted:
2023-11-15
First Post:
2007-06-07
Brief Title:
STARBRITE A Randomized Pilot Trial of BNP-Guided Therapy in Patients With Advanced Heart Failure
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Strategies for Tailoring Advanced Heart Failure Regimens in the Outpatient Setting Brain Natriuretic Peptide Levels Versus the Clinical Congestion Score
Status:
COMPLETED
Status Verified Date:
2007-06
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:
STARBRITE
Brief Summary:
The primary hypothesis is that in patients with advanced heart failure an outpatient fluid management strategy guided by BNP levels and clinical targets will lead to fewer days hospitalized or dead over a 3-month period compared to an outpatient fluid management strategy using clinical targets alone
Detailed Description:
STARBRITE will test the hypothesis that a defined fluid management strategy tailored to specific symptoms and physiological targets will improve morbidity and mortality in the advanced heart failure population Individual targets for each patient will be based on the outcome of the index hospitalization during which therapy is adjusted to optimize clinical status blood pressure and renal function Identifying a standard fluid management strategy may be an important way to limit the complications of diuretic therapy and the duration of hospitalization for these patients In addition a standard approach may provide objective criteria that can be used to systematically deliver care in many types of clinical settings
In this study patients will be randomized to two strategies of outpatient fluid management 1 the Congestion Score Strategy and 2 the BNP Strategy
In this study patients will be randomized to two strategies of outpatient fluid management 1 the Congestion Score Strategy and 2 the BNP Strategy
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 0335132N | None | None | None |