NCT00166127

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_3 heart-failure

Timeline
Completed

Started May 2005

Shorter than P25 for phase_3 heart-failure

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
Last Updated

November 15, 2013

Status Verified

November 1, 2013

First QC Date

September 12, 2005

Last Update Submit

November 13, 2013

Conditions

Heart Failure

Keywords

heart failurecardiac surgerypharmacokineticspharmacodynamics

Outcome Measures

Primary Outcomes (1)

  • pharmacokinetics

    day of surgery

Secondary Outcomes (1)

  • hemodynamics

    day of surgery

Interventions

LevosimendanDRUG

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Emergency surgery
  • Withdrawal of consent
  • Uncontrollable ventricular arrhythmias
  • Obstructive cardiomyopathy
  • Confirmed pregnancy test for women of child-bearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Jerrold H Levy, MD

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

May 1, 2005

Study Completion

January 1, 2007

Last Updated

November 15, 2013

Record last verified: 2013-11

Locations

US(1)