Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00252187
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2005-11-10
Brief Title:
Cardiac Hormone Replacement With Brain Natriuretic Peptide BNP in Heart Failure
Sponsor:
Horng Chen
Organization:
Mayo Clinic
Study Overview
Official Title:
Cardiac Hormone Replacement With BNP in Heart Failure A Novel Therapeutic Strategy
Status:
COMPLETED
Status Verified Date:
2012-12
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:
SubqBNP
Brief Summary:
The purpose of this study is to determine the effects of subcutaneous injection of Human BNP nesiritide a hormone produced by the heart on the pumping ability of the heart kidney function and hormonal function in persons with heart failure
Detailed Description:
The cardiac hormone brain natriuretic peptide BNP plays an important role in the pathophysiology of congestive heart failure CHF Studies have established that BNP mediates natriuresis renin and aldosterone RAAS inhibition vasodilation and lusitropism Acute cardiac hormone replacement with intravenous infusion of BNP has been shown to possess potent vasodilating actions in humans with acute decompensated CHF resulting in improvement of clinical symptoms Natrecor nesiritide a sterile purified preparation of human BNP is approved by the FDA for intravenous administration in the treatment of patients with acute decompensated congestive heart failure However chronic cardiac hormone replacement with BNP as therapeutic strategy in CHF has been limited by the need to administer BNP intravenously The objective of this study is to define the cardiorenal and humoral actions of short term eight weeks chronic cardiac hormone replacement with subcutaneous SQ BNP in human NYHA class II-III CHF Systolic and diastolic function left ventricular remodeling as assessed by its volume renal function neurohumoral profiling and exercise capacity will be assessed prior to and after eight weeks of treatment
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 |
|---|---|---|---|
| UL1RR024150 | NIH | None | httpsreporternihgovquickSearchUL1RR024150 |
| R01HL036634 | NIH | None | None |
| R01HL084155 | NIH | None | None |
| P01HL076611 | NIH | None | None |