Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-25 @ 3:04 PM
Study NCT ID:
NCT00309868
Status:
COMPLETED
Last Update Posted:
2014-03-26
First Post:
2006-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Nesiritide in Diastolic Heart Failure.
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
A Study of the Acute Hemodynamic and Myocardial Effects of Nesiritide in Diastolic Heart Failure.
Status:
COMPLETED
Status Verified Date:
2014-03
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:
We hypothesize that nesiritide will have favorable effect in decreasing heart filling pressures and echocardiogram studies.
Detailed Description:
In previous studies, patients with systolic heart failure were given nesiritide and had reduced heart filling pressures. The FDA has approved nesiritide for these patients.
Between one-third and one-half of patients with heart failure have diastolic heart failure. Few of these patients have been studied while receiving nesiritide.
A study is needed to test nesiritide on this specific type of heart failure.
Patients will undergo a heart catheterization and heart biopsy. Patients will then be transferred to the intensive care unit for monitoring. An echocardiogram will be obtained, followed by an infusion of nesiritide for 24 hours. At the completion of the infusion, a repeat echocardiogram will be obtained.
Between one-third and one-half of patients with heart failure have diastolic heart failure. Few of these patients have been studied while receiving nesiritide.
A study is needed to test nesiritide on this specific type of heart failure.
Patients will undergo a heart catheterization and heart biopsy. Patients will then be transferred to the intensive care unit for monitoring. An echocardiogram will be obtained, followed by an infusion of nesiritide for 24 hours. At the completion of the infusion, a repeat echocardiogram will be obtained.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: