Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery
Primary Purpose
Heart Failure
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Levosimendan
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring heart failure, cardiac surgery, pharmacokinetics, pharmacodynamics
Eligibility Criteria
Inclusion Criteria: At least 21 years of age Less than 80 years of age ASA Class III-IV Scheduled for elective cardiac surgery Signed informed consent History of heart failure, and/or left ventricular ejection fraction <50% Exclusion Criteria: Emergency surgery Withdrawal of consent Uncontrollable ventricular arrhythmias Obstructive cardiomyopathy Confirmed pregnancy test for women of child-bearing potential
Sites / Locations
- Emory University Hospital
Outcomes
Primary Outcome Measures
pharmacokinetics
Secondary Outcome Measures
hemodynamics
Full Information
NCT ID
NCT00166127
First Posted
September 12, 2005
Last Updated
November 13, 2013
Sponsor
Emory University
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT00166127
Brief Title
Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery
Official Title
Pharmacokinetics and Pharmacodynamics of Levosimendan During Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Unable to renegotiate an expired contract w/sponsor providing study med
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Emory University
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 subject's enrollment ends at Day 7 or day of discharge, whichever comes first.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, cardiac surgery, pharmacokinetics, pharmacodynamics
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Primary Outcome Measure Information:
Title
pharmacokinetics
Time Frame
day of surgery
Secondary Outcome Measure Information:
Title
hemodynamics
Time Frame
day of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
At least 21 years of age
Less than 80 years of age
ASA Class III-IV
Scheduled for elective cardiac surgery
Signed informed consent
History of heart failure, and/or left ventricular ejection fraction <50%
Exclusion Criteria:
Emergency surgery
Withdrawal of consent
Uncontrollable ventricular arrhythmias
Obstructive cardiomyopathy
Confirmed pregnancy test for women of child-bearing potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerrold H Levy, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery
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