Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00240084
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2005-10-13
Brief Title:
Nesiritide and Vo2 Max in Heart Failure Patients
Sponsor:
University of Rochester
Organization:
University of Rochester
Study Overview
Official Title:
Nesiritide and Vo2 Max in Heart Failure Patients
Status:
COMPLETED
Status Verified Date:
2013-06
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:
None
Brief Summary:
This research study funded by Scios Inc and conducted by the Cardiology Division of the Department of Medicine at the University of Rochester School of Medicine and Dentistry investigates the potential benefit of nesiritide brand name is NatrecorTMin improving exercise capacity in patients with heart failure HF Previous studies have shown beneficial hemodynamic and neurohumoral effects of nesiritide infusion in the therapy of decompensated heart failure Other studies have demonstrated increases in endogenous BNP levels normalized for exercise workload in HF patients during and after exercise However trials involving the measurement of exercise capacity in this population following BNP administration are lacking This is an experimental prospective non-blinded pilot study with a sample size of 20 patients all serving as their own controls This study involves off-label use of the drug nesiritide indicated for IV treatment of NYHA Class II and III patients and this study is enrolling Class II and III patients and has received FDA approval and an IND Subjects are recruited from the population of referrals to the Strong Memorial Hospital Heart Failure and Transplantation clinical service who meet all the inclusion criteria and none of the exclusion criteria may participate in the study Enrolled study subjects perform an exercise VO2 max test receive a 24 hour infusion of nesiritide and perform a second exercise VO2 max test
Detailed Description:
See above comments
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