Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166127
Status:
TERMINATED
Last Update Posted:
2013-11-15
First Post:
2005-09-12
Brief Title:
Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery
Sponsor:
Emory University
Organization:
Emory University
Study Overview
Official Title:
Pharmacokinetics and Pharmacodynamics of Levosimendan During Cardiac Surgery
Status:
TERMINATED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to renegotiate an expired contract wsponsor providing study med
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 protocol is to evaluate the blood concentrations of levosimendan when administered at different doses clinically employed during cardiopulmonary bypass or cardiac manipulation during off pump surgery in patients who require the drug for inotropic support improved heart function and the associated hemodynamic variables vital signs Levosimendan is one of the first agents in a new class of drugs used to treat heart failure and works via a unique mechanism called calcium sensitization that makes the heart beat more efficiently Levosimendan also has unique effects on the blood vessels as well as causing relaxation an important therapeutic approach of heart failure therapy
Detailed Description:
This is a non-randomized trial and the patients will be assigned to one of three dose groups following cardiopulmonary bypass or prior to manipulation of the heart in the off pump group A total of 30 patients will be enrolled into this study 20 off-pump and 10 subjects on pump Levosimendan is approved in Europe for the treatment of decompensated heart failure It improved cardiac function without increasing energy demands The subjects enrollment ends at Day 7 or day of discharge whichever comes first
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 |
|---|---|---|---|
| 6-38989 | None | None | None |