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

This study has been terminated.
(Unable to renegotiate an expired contract w/sponsor providing study med)
Sponsor:
Collaborator:
Abbott
Information provided by:
Emory University
ClinicalTrials.gov Identifier:
NCT00166127
First received: September 12, 2005
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: Levosimendan
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetics and Pharmacodynamics of Levosimendan During Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • pharmacokinetics [ Time Frame: day of surgery ]

Secondary Outcome Measures:
  • hemodynamics [ Time Frame: day of surgery ]

Enrollment: 1
Study Start Date: May 2005
Study Completion Date: January 2007
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.

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166127

Locations
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Abbott
Investigators
Principal Investigator: Jerrold H Levy, MD Emory University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00166127     History of Changes
Other Study ID Numbers: 0984-2003, 6-38989
Study First Received: September 12, 2005
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Emory University:
heart failure
cardiac surgery
pharmacokinetics
pharmacodynamics

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014