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