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Clinical trial

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

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Last updated:1st Apr 2010
Identifier: NCT01536132

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.

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
Primary Completion Date: October 2013
Study Completion Date: November 2015

Arms and Interventions:
- Active Comparator:
- Placebo Comparator: Placebo

Related journal:
- Efficacy and safety of intermittent intravenous outpatient administration of levosimendan in patients with advanced heart failure: the LION-HEART multicentre randomised trial.

Category Value
Date last updated at source 2016-02-17
Study type(s) Interventional
Expected enrolment 70
Study start date 2010-04-01
Estimated primary completion date 2013-10-01

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