NCT01065194

Brief Summary

The purpose of this study is to compare the effects of a pulsed application of Levosimendan versus placebo on the composite end-point functional capacity and quality of life.

Trial Health

47
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Aug 2009

Geographic Reach
2 countries

11 active sites

Status
unknown

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

August 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 30, 2010

Status Verified

August 1, 2009

Enrollment Period

2 years

First QC Date

February 8, 2010

Last Update Submit

August 27, 2010

Conditions

Chronic Stable Heart Failure

Outcome Measures

Primary Outcomes (1)

  • proportion of patients showing an improvement in the six-minutes walk test and a higher scoring in the Kansas City Cardiomyopathy Questionnaire (KCCQ)

    24 weeks

Secondary Outcomes (2)

  • effects of a pulsed application of levosimendan on event free survival

    8 weeks from randomization

  • effects of a pulsed application of levosimendan on event free survival

    24 weeks from randomization

Study Arms (2)

Levosimendan

EXPERIMENTAL

Chronic stable heart failure

Drug: Levosimendan

Placebo

PLACEBO COMPARATOR

Chronic Stable Heart Failure

Drug: Placebo

Interventions

LevosimendanDRUG

Levosimendan will be infused on an outpatient basis for six hours at a dosage of 0,2 μg/kg/min without a bolus

Levosimendan
PlaceboDRUG

Levosimendan will be infused on an outpatient basis for six hours at a dosage of 0,2 μg/kg/min without a bolus.

Placebo

Eligibility Criteria

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

You may qualify if:

  • min.-walk-test \< 350 meters
  • EF \< 35 %
  • Age \> 20 years
  • Optimized and individualised neurohormonal background therapy according to ESC-guidelines for the treatment of chronic heart failure.
  • Patient has signed informed consent

You may not qualify if:

  • Hospitalization for decompensated heart failure requiring i.v. diuretics within the last month before randomization
  • History of torsades des pointes
  • Allergy to Levosimendan or any of the excipients
  • Administration of inotropes in the last 4 weeks
  • Potassium \<3,5 and \>5,5 mmol/l
  • Systolic blood pressure \<= 100 mmHg
  • Women at childbearing age without using effective contraceptives ( oral contraceptives, intrauterine contraceptive devices) unless surgical sterilisation has been undertaken.
  • Female patients who are pregnant or nursing
  • Creatinin Clearance \< 30ml/min/m2
  • Severe anemia (Hb \< 10 mg /dl)
  • Mechanical obstruction affecting the ventricular filling or the outflow or both
  • Patients with non compliance
  • Severe conditions, which make the patient unsuitable to participate in a study as judged by the investigator
  • Severe liver disease
  • Percutaneous coronary intervention within the last 1 months
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Medical University Innsbruck

Innsbruck, 6020, Austria

RECRUITING

Allg. öffentliches Krankenhaus der Elisabethinen

Linz, 4010, Austria

RECRUITING

Krankenhaus der Barmherzigen Schwestern

Linz, 4010, Austria

RECRUITING

Allgemeine Krankenhaus der Stadt Linz

Linz, 4021, Austria

RECRUITING

Paracelsus Medical University Salzburg

Salzburg, 5020, Austria

RECRUITING

Landesklinikum St. Poelten

Sankt Pölten, 3100, Austria

RECRUITING

Kaiserin Elisabeth Spital Vienna

Vienna, 1150, Austria

RECRUITING

Klinikum Wels Grieskirchen

Wels, 4600, Austria

RECRUITING

G. Gennimatas General Hospital

Athens, 11527, Greece

RECRUITING

Hippokration General Hospital

Athens, 11527, Greece

RECRUITING

Heart Failure Clinic, Attikon University Hospital

Athens, 12461, Greece

RECRUITING

Related Publications (1)

  • Altenberger J, Parissis JT, Costard-Jaeckle A, Winter A, Ebner C, Karavidas A, Sihorsch K, Avgeropoulou E, Weber T, Dimopoulos L, Ulmer H, Poelzl G. Efficacy and safety of the pulsed infusions of levosimendan in outpatients with advanced heart failure (LevoRep) study: a multicentre randomized trial. Eur J Heart Fail. 2014 Aug;16(8):898-906. doi: 10.1002/ejhf.118. Epub 2014 Jun 11.

    PMID: 24920349DERIVED

MeSH Terms

Interventions

Simendan

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Johann Altenberger, MD

    Paracelsus Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johann Altenberger, MD

CONTACT

+436624482j.altenberger@salk.at

Gerhard Poelzl, MD

CONTACT

+43512504gerhard.poelzl@uki.at

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

August 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 30, 2010

Record last verified: 2009-08

Locations

GR(3)AU(8)