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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Parc de Salut Mar
ClinicalTrials.gov Identifier:
NCT01536132
First received: February 15, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Heart Failure
Drug: Levosimendan
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Chronic Heart Failure: the LION-HEART Study

Resource links provided by NLM:


Further study details as provided by Parc de Salut Mar:

Primary Outcome Measures:
  • Changes of natriuretic peptide levels between baseline and end of treatment. [ Time Frame: 3 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality . [ Time Frame: from baseline to end of follow-up (12 months). ] [ Designated as safety issue: Yes ]
  • Hospitalisation. [ Time Frame: from baseline to end of follow-up (12 months). ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: April 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Levosimendan Drug: Levosimendan
0.2 micrograms/kg/min is administered intravenously without bolus for 6 hours every two weeks.
Placebo Comparator: Placebo Drug: Placebo
Placebo (same appearance than active drug) is administered with the same dosing regime

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536132

Locations
Spain
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
  More Information

No publications provided

Responsible Party: Parc de Salut Mar
ClinicalTrials.gov Identifier: NCT01536132     History of Changes
Other Study ID Numbers: IMIM-LEV-0901
Study First Received: February 15, 2012
Last Updated: November 20, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Parc de Salut Mar:
Levosimendan
chronic heart failure
inotropic drug

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

ClinicalTrials.gov processed this record on August 20, 2014