NCT01318460

Brief Summary

The present pilot study aims to investigate the effectiveness of the preoperative infusion of levosimendan in patients with impaired left ventricular function undergoing coronary artery bypass grafting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_4 coronary-artery-disease

Timeline
Completed

Started Mar 2011

Typical duration for phase_4 coronary-artery-disease

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, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

May 7, 2019

Status Verified

May 1, 2019

Enrollment Period

3 years

First QC Date

March 17, 2011

Last Update Submit

May 4, 2019

Conditions

Coronary Artery Disease

Keywords

coronary artery diseaselevosimendancoronary artery bypass graftingcardiac surgery

Outcome Measures

Primary Outcomes (1)

  • Left ventricular function

    Left ventricular function as assessed by transthoracic or transesophageal echocardiography on the seventh postoperative day

    Seventh postoperative day

Secondary Outcomes (8)

  • Perioperative mortality

    30 days postoperatively

  • Need for intraaortic balloon pump

    1st-7th postoperative day

  • Inotropic support

    1st-7th postoperative day

  • Total ICU stay

    1st-7th postoperative day

  • Total length of hospital stay

    1st-7th postoperative day

  • +3 more secondary outcomes

Study Arms (2)

Levosimendan

ACTIVE COMPARATOR

Patients treated with prophylactic administration of levosimendan

Drug: Levosimendan infusion

Placebo group

PLACEBO COMPARATOR

Patients managed with placebo administration

Drug: Placebo infusion

Interventions

Levosimendan infusionDRUG

Prophylactic 24h infusion of levosimendan at a dose of 0.1 mg/kg/min

Levosimendan
Placebo infusionDRUG

Twenty-four hour administration of placebo

Placebo group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • coronary artery disease which warrants myocardial revascularization with coronary artery bypass grafting according to current guidelines
  • age \< 79 years old
  • left ventricular ejection fraction \<= 40%
  • informed patient's consent

You may not qualify if:

  • age \< 18 years old
  • emergency surgery
  • medical history of acute myocardial infarction with ST elevation (STEMI) less than 14 days old
  • any severe comorbidity which increases the perioperative risk (i.e. neoplasia, rheumatoid arthritis, chronic obstructive pulmonary disease)
  • need for valvular replacement surgery
  • redo surgery
  • serum creatinine \> 2 mg/dl
  • history of malignant cardiac arrhythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiothoracic Surgery, AHEPA University Hospital

Thessaloniki, 546 36, Greece

Location

Related Publications (3)

  • De Hert SG, Lorsomradee S, Cromheecke S, Van der Linden PJ. The effects of levosimendan in cardiac surgery patients with poor left ventricular function. Anesth Analg. 2007 Apr;104(4):766-73. doi: 10.1213/01.ane.0000256863.92050.d3.

    PMID: 17377079BACKGROUND

  • Tasouli A, Papadopoulos K, Antoniou T, Kriaras I, Stavridis G, Degiannis D, Geroulanos S. Efficacy and safety of perioperative infusion of levosimendan in patients with compromised cardiac function undergoing open-heart surgery: importance of early use. Eur J Cardiothorac Surg. 2007 Oct;32(4):629-33. doi: 10.1016/j.ejcts.2007.07.010. Epub 2007 Aug 15.

    PMID: 17702589BACKGROUND

  • Kolseth SM, Nordhaug DO, Stenseth R, Sellevold O, Kirkeby-Garstad I, Wahba A. Prophylactic treatment with levosimendan: a retrospective matched-control study of patients with reduced left ventricular function. Eur J Cardiothorac Surg. 2009 Dec;36(6):1024-30. doi: 10.1016/j.ejcts.2009.05.001. Epub 2009 Jul 9.

    PMID: 19592266BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Kyriakos Anastasiadis, MD, FETCS

    AHEPA University Hospital

    PRINCIPAL INVESTIGATOR

  • Christos Papakonstantinou, MD

    AHEPA University Hospital

    STUDY CHAIR

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
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Cardiothoracic Department

Study Record Dates

First Submitted

March 17, 2011

First Posted

March 18, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

May 7, 2019

Record last verified: 2019-05

Locations

GR(1)