Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00475852
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2007-05-18
Brief Title:
A Study Testing the Effectiveness of Nesiritide in Patients With Acute Decompensated Heart Failure
Sponsor:
Scios Inc
Organization:
Scios Inc
Study Overview
Official Title:
Double-Blind Placebo-Controlled Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure ASCEND-HF
Status:
COMPLETED
Status Verified Date:
2013-03
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 purpose of this study is to find out if nesiritide a human B-type natriuretic peptidehBNP as compared to placebo plus the usual treatment for acute decompensated heart failure helps to improve breathing difficulties reduce heart failure readmissions to hospitals and helps patients live longer
Detailed Description:
Acute Decompensated Heart Failure ADHF is the inability of the heart to pump efficiently which can result in symptoms like shortness of breath at rest or with minimal activity ADHF is a condition in which the heart cannot perform the necessary circulation of blood through the body This is a randomized study medication is assigned by chance double-blind neither the patient or the doctor knows whether the patient is assigned to receive study drug or placebo does not contain study drug placebo-controlled parallel group multicenter study of the effectiveness of nesiritide administered continuously through a vein for a minimum of 24 hours up to a maximum of 7 days The study hypothesis is that nesiritide given in addition to standard care is superior to placebo given in addition to standard care as measured by relief of breathing difficulties by patient evaluation utilizing a breathlessness scale at 6 hours or 24 hours after nesiritide administration and reduction in rehospitalization due to heart failure and death from study drug administration through Day 30 The study drug nesiritide or placebo dose being studied is 0010 mcgkgmin with or without a 2 mcgkg initial bolus one time injection of nesiritide Patient safety will be monitored throughout the study through physical exams vital signs heart rate blood pressure respiratory rate and temperature blood tests and side effects The patients assigned to the nesiritide group will receive a continuous intravenous into a vein infusion at 0010 mcgkgmin of nesiritide with or without a 2 mcgkg bolus one time injection The patients assigned to the placebo group will receive matching placebo bolus and infusion The bolus is given over one minute and the continuous infusion is given for at least 24 hours and up to 7 days
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 |
|---|---|---|---|
| NATRECORAHF3002 | OTHER | Johnson Johnson Pharmaceutical Research Development LLC | None |
| ASCEND-HF | OTHER | None | None |
| A093 | OTHER | None | None |