NCT00130871

Brief Summary

The study evaluates the efficacy of intravenous levosimendan treatment started during a coronary artery bypass operation to wean patients from a heart lung machine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2005

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

February 21, 2007

Status Verified

February 1, 2007

First QC Date

August 15, 2005

Last Update Submit

February 19, 2007

Conditions

Coronary Heart Disease

Keywords

levosimendanweaningcardio-pulmonary bypass

Outcome Measures

Primary Outcomes (1)

  • Proportion of successful primary weanings

Interventions

levosimendanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Three vessel coronary artery disease.
  • Indication for on-pump coronary artery bypass surgery.
  • Ejection fraction below 50%

You may not qualify if:

  • Indication for any cardiac valve surgery
  • Previous coronary artery bypass surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Helsinki University Central Hospital

Helsinki, 00290, Finland

Location

Turku University Central Hospital

Turku, Finland

Location

MeSH Terms

Conditions

Coronary Disease

Interventions

Simendan

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Markku Salmenperä, MD

    Helsinki University Central Hospital, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 16, 2005

Study Start

January 1, 2004

Study Completion

January 1, 2006

Last Updated

February 21, 2007

Record last verified: 2007-02

Locations

FI(2)