NCT00154115

Brief Summary

Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Study hypothesis: Levosimendan diminishes the need for adrenergic inotropic drugs and morbidity and may improve survival after heart valve surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P50-P75 for phase_4 heart-failure

Timeline
Completed

Started Mar 2005

Typical duration for phase_4 heart-failure

Geographic Reach
1 country

1 active site

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

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 21, 2009

Status Verified

January 1, 2009

Enrollment Period

3.8 years

First QC Date

September 7, 2005

Last Update Submit

January 20, 2009

Conditions

Heart Failure

Keywords

heart failurelevosimendancardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Heart failure necessitating inotropic drug administering after heart valve surgery

    Postoperative hospital period

Secondary Outcomes (2)

  • Hospital morbidity and mortality

    Postoperative hospital period

  • Postoperative mortality at six months

    Six months postoperatively

Study Arms (2)

1

EXPERIMENTAL

Levosimendan

Drug: levosimendan

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

levosimendanDRUG

Intravenous infusion, blus 24 mcg/kg in 30-minutes followed by 0.2 mcg/kg/min up to 24 hours

1
placeboDRUG

Placebo

2

Eligibility Criteria

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

You may qualify if:

  • Eligible for cardiac valve or combined CABG and cardiac valve surgery:
  • Clinical signs of cardiac insufficiency

You may not qualify if:

  • Endocarditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kuopio University Hospital

Kuopio, 70210, Finland

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

  • Pasi K Lahtinen, MD

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 7, 2005

First Posted

September 12, 2005

Study Start

March 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 21, 2009

Record last verified: 2009-01

Locations

FI(1)