Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery

Heart Failure Clinical Trial

Official title:

Pharmacokinetics and Pharmacodynamics of Levosimendan During Cardiac Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00166127
• Other study ID #: 0984-2003
• Secondary ID: 6-38989
• Status: Terminated
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: November 13, 2013
• Start date: May 2005
• Est. completion date: January 2007

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Levosimendan

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pharmacokinetics		day of surgery
Secondary	hemodynamics		day of surgery