NCT00324766

Brief Summary

The purpose of this study is to determine the safety and efficacy of a 24 hour infusion with levosimendan in patients with acute myocardial infarction and heart failure after acute percutaneous coronary intervention (PCI) treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

May 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 11, 2006

Completed
21 days until next milestone

Study Start

First participant enrolled

June 1, 2006

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

5.3 years

First QC Date

May 10, 2006

Last Update Submit

June 25, 2012

Conditions

Myocardial InfarctionHeart FailureCardiogenic Shock

Outcome Measures

Primary Outcomes (1)

  • Efficacy: Changes in regional contractility measured as wall-motion score index, proBNP and clinical symptoms.

    Changes in regional contractility (WMSI) measured by echo is the primary endpoint in the study and the sample size calculation is based on expected differenced in WMSI from baseline to day 5 between groups.

    At 5 days

Secondary Outcomes (11)

  • Mace: Time to death, non-fatal myocardial infarction or revascularization during the first 6 weeks and 6 months.

    6 months

  • Time to rehospitalisation for decompensated heart failure.

    6 months

  • Days hospitalised/days in intensive/coronary care.

    At discharge

  • Changes in inflammation markers.

    1, 5 days, 6 weeks.

  • Improvement in creatinine clearance.

    5 days

  • +6 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

levosimendan

Drug: levosimendan

2

PLACEBO COMPARATOR

Placebo, 1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min

Drug: placebo,

Interventions

levosimendanDRUG

1 h infusion, 0.2 microgs/kg/min, 24 h infusion,0.1 microgs/kg/min

Also known as: Simdax
1
placebo,DRUG

24 h, infusion

Also known as: placebo
2

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute ST-elevation myocardial infarction subject to acute PCI or non-ST elevation myocardial infarction subject to PCI within 72 hours after start of chest pain and:
  • Revascularization by PCI,
  • Signs of decreased wall-motion in at least 3 of 16 segments of the left ventricle
  • Dyspnoea at rest and one of the following:
  • pulmonary edema, pulmonary congestion,need for CPAP or ventilator, need for IC diuretics or oliguria.
  • Subgroup of patients in cardiogenic shock: Systolic BP below 90 after 1 hour of volume therapy.

You may not qualify if:

  • Age below 20 years
  • Heart rate above 120 bpm
  • Septic shock
  • ARDS
  • Creatinine \>450 micromol/l
  • Hepatic impairment
  • Significant mechanical outlet obstruction
  • Allergy against study drug medication
  • Anaemia (Hb \<8 g/dl)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Ulleval University Hospital

Oslo, N-0852, Norway

Location

Related Publications (3)

  • Langseth MS, Andersen GO, Husebye T, Arnesen H, Zucknick M, Solheim S, Eritsland J, Seljeflot I, Opstad TB, Helseth R. Neutrophil extracellular trap components and myocardial recovery in post-ischemic acute heart failure. PLoS One. 2020 Oct 29;15(10):e0241333. doi: 10.1371/journal.pone.0241333. eCollection 2020.

    PMID: 33119664DERIVED

  • Husebye T, Eritsland J, Arnesen H, Bjornerheim R, Mangschau A, Seljeflot I, Andersen GO. Association of interleukin 8 and myocardial recovery in patients with ST-elevation myocardial infarction complicated by acute heart failure. PLoS One. 2014 Nov 12;9(11):e112359. doi: 10.1371/journal.pone.0112359. eCollection 2014.

    PMID: 25390695DERIVED

  • Husebye T, Eritsland J, Muller C, Sandvik L, Arnesen H, Seljeflot I, Mangschau A, Bjornerheim R, Andersen GO. Levosimendan in acute heart failure following primary percutaneous coronary intervention-treated acute ST-elevation myocardial infarction. Results from the LEAF trial: a randomized, placebo-controlled study. Eur J Heart Fail. 2013 May;15(5):565-72. doi: 10.1093/eurjhf/hfs215. Epub 2013 Jan 2.

    PMID: 23288914DERIVED

MeSH Terms

Conditions

Myocardial InfarctionHeart FailureShock, Cardiogenic

Interventions

Simendan

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShock

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Trygve Husebye, MD,

    Department of Cardiology, Ulleval University Hospital

    PRINCIPAL INVESTIGATOR

  • Geir Ø Andersen, MD, PhD

    Department of Cardiology, Ulleval University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2006

First Posted

May 11, 2006

Study Start

June 1, 2006

Primary Completion

September 1, 2011

Study Completion

March 1, 2012

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations

NO(1)