NCT01536132

Brief Summary

The purpose of this study is to determine the safety and efficacy of intravenous administration of intermittent doses of levosimendan (infusions of 0,2 μg/kg/min, of levosimendan or placebo, without bolus, for 6 hours every 2 weeks) compared to placebo in ambulatory patients with advanced chronic heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_4 heart-failure

Geographic Reach
1 country

13 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

April 1, 2010

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 20, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 17, 2016

Status Verified

February 1, 2016

Enrollment Period

3.5 years

First QC Date

February 15, 2012

Last Update Submit

February 13, 2016

Conditions

Heart Failure

Keywords

Levosimendanchronic heart failureinotropic drug

Outcome Measures

Primary Outcomes (1)

  • Changes of natriuretic peptide levels between baseline and end of treatment.

    3 months.

Secondary Outcomes (2)

  • Mortality .

    from baseline to end of follow-up (12 months).

  • Hospitalisation.

    from baseline to end of follow-up (12 months).

Study Arms (2)

Levosimendan

ACTIVE COMPARATOR

levosimendan at a dose of 0.2 micrograms/kg/min for 6 hours intravenous infusion

Drug: Levosimendan

Placebo

PLACEBO COMPARATOR

placebo (same appereance than levosimendan in colour) at a dose of 0.2 micrograms/kg/min for 6 hours intravenous infusion

Drug: Placebo

Interventions

LevosimendanDRUG

0.2 micrograms/kg/min is administered intravenously without bolus for 6 hours every two weeks.

Also known as: SIMDAX (trade mark)
Levosimendan
PlaceboDRUG

Placebo (same appearance than active drug) is administered with the same dosing regime

Placebo

Eligibility Criteria

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

You may qualify if:

  • qged more than 18,
  • left ventricular ejection fraction below 35%,
  • diagnostic criteria of advanced chronic heart failure.

You may not qualify if:

  • Conduction abnormalities (auricular ventricular block),
  • malignant arrythmias,
  • recent administration of inotropic drugs,
  • recent acute coronary syndrome,
  • recent cerebrovascular accident,
  • glomerular filtration rate below 30,
  • systolic blood pressure below 90 mmhg.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital de Sant Pau

Barcelona, Barcelona, 08040, Spain

Location

Hospital de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Valdecillas

Santander, Cantabria, 39008, Spain

Location

Hospital Doce de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Puerta de Hierro

Majadahonda, Madrid, 28222, Spain

Location

Hospital Virgen de la Victoria

Málaga, Malaga, 29010, Spain

Location

Hospistal Central Asturias

Oviedo, Principality of Asturias, 33006, Spain

Location

Complexo Hospitalario A Coruña

A Coruña, Spain, 15006, Spain

Location

Hospital Virgen Arrixaca

Murcia, Spain, 41013, Spain

Location

Hospital Virgen del Rocío

Seville, Spain, 41013, Spain

Location

Hospital la Fe

Valencia, Spain, 46026, Spain

Location

Hospital Miguel Servet

Zaragoza, Zaragoza, 50009, Spain

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

  • JOSEP COMIN COLET, MD PHD

    HOSPITAL DEL MAR MEDICAL RESEARCH INSTITUTE

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

February 15, 2012

First Posted

February 20, 2012

Study Start

April 1, 2010

Primary Completion

October 1, 2013

Study Completion

November 1, 2015

Last Updated

February 17, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(13)