Intermittent Intravenous Levosimendan in Ambulatory Advanced Chronic Heart Failure Patients (LION-HEART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01536132
Recruitment Status : Completed
First Posted : February 20, 2012
Last Update Posted : February 17, 2016
Information provided by (Responsible Party):
Josep Comín, Parc de Salut Mar

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.

Condition or disease Intervention/treatment Phase
Heart Failure Drug: Levosimendan Drug: Placebo Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Double-blind, Placebo-controlled Randomized Trial to Evaluate the Efficacy and Safety of Intravenous Administration of Intermittent Doses of Levosimendan in Ambulatory Patients With Advanced CHF: the LION-HEART Study
Study Start Date : April 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: Levosimendan
levosimendan at a dose of 0.2 micrograms/kg/min for 6 hours intravenous infusion
Drug: Levosimendan
0.2 micrograms/kg/min is administered intravenously without bolus for 6 hours every two weeks.
Other Name: SIMDAX (trade mark)

Placebo Comparator: Placebo
placebo (same appereance than levosimendan in colour) at a dose of 0.2 micrograms/kg/min for 6 hours intravenous infusion
Drug: Placebo
Placebo (same appearance than active drug) is administered with the same dosing regime

Primary Outcome Measures :
  1. Changes of natriuretic peptide levels between baseline and end of treatment. [ Time Frame: 3 months. ]

Secondary Outcome Measures :
  1. Mortality . [ Time Frame: from baseline to end of follow-up (12 months). ]
  2. Hospitalisation. [ Time Frame: from baseline to end of follow-up (12 months). ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01536132

Hospistal Central Asturias
Oviedo, Asturias, Spain, 33006
Hospital de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
Complexo Hospitalario A Coruña
A Coruña, Spain, 15006
Hospital del Mar
Barcelona, Spain, 08003
Hospital de Sant Pau
Barcelona, Spain, 08040
Hospital Doce de Octubre
Madrid, Spain, 28041
Hospital Virgen de la Victoria
Malaga, Spain, 29010
Hospital Virgen Arrixaca
Murcia, Spain, 41013
Hospital Valdecillas
Santander, Spain, 39008
Hospital Virgen del Rocío
Sevilla, Spain, 41013
Hospital la Fe
Valencia, Spain, 46026
Hospital Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Parc de Salut Mar

Responsible Party: Josep Comín, MD, Parc de Salut Mar Identifier: NCT01536132     History of Changes
Other Study ID Numbers: IMIM-LEV-0901
First Posted: February 20, 2012    Key Record Dates
Last Update Posted: February 17, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Josep Comín, Parc de Salut Mar:
chronic heart failure
inotropic drug

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs