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

Pharmacokinetics and Pharmacodynamics of Levosimendan During Cardiac Surgery

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00166127

Enrollment

Registered

2005-09-14

Start date

2005-05-31

Completion date

2007-01-31

Last updated

2013-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, cardiac surgery, pharmacokinetics, pharmacodynamics

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.

Interventions

DRUGLevosimendan

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
pharmacokinetics	day of surgery

Secondary

Measure	Time frame
hemodynamics	day of surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026