NCT00988806

Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure

Double-blind Randomized Placebo-controlled Study to Evaluate the Efficacy and Safety of Intermittent, Long-term Administration of Levosimendan in Patients With Advanced Heart Failure

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 213 (estimated)
• Sponsor: Hospital Universitario de Canarias · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether the treatment strategy of long-term intermittent every 30 days, continuous intravenous infusion for 24 hours of Levosimendan, associated to optimal contemporary treatment for advanced heart failure reduce the incidence of admission for heart failure worsening at 12 months follow up, compared with the strategy based solely in the optimal contemporary treatment for advanced heart failure.

Detailed description

Aims: To evaluate the efficacy and safety of long-term, intermittent intravenous administration for 24 hours of Levosimendan for the treatment of advanced heart failure. Main end-point: incidence of admission due to decompensation, defined as first admission to emergency services or hospitalization more than 12 hours due to heart failure worsening. Secondary end-points: major cardiac events, serious adverse events, change in NYHA scale at baseline, 30 days, 6 and 12 months; effects on inflammatory and neurohormonal activation in heart failure, identify factors associated with better survival of patients, quality of life, cost-effectiveness of treatment. Study Design: Prospective, randomized, double-blind placebo controlled trial. Scope of the study: patients with advanced heart failure. Study Subjects: Patients over 18 years old with advanced HF of any etiology, with at least one admission for acute decompensation treated or treatable with Levosimendan within 6 months prior to randomization. Interventions: a 24-hour infusion every 30 days of Levosimendan or placebo in addition to optimal pharmacological treatment for HF during 12 months. Determinations: clinical monitoring, protocol-specified analytical determinations, echocardiographic assessment, invasive hemodynamic assessment, functional assessment by 6 min walk test in corridor, quality of life assessment at baseline, after 30 days, 6 months and 12 months.

Conditions

• Advanced Heart Failure

Interventions

Type	Name	Description
DRUG	Levosimendan	Patients included in the intervention group receive optimal drug therapy for heart failure symptoms and also infusion of levosimendan at doses of 0.1 mcg / kg / min for 24 hours every 30 days. Failure to reach an appropriate level of heart failure compensation before the deadline of 30 days for the next study drug administration or placebo, the administration of them will be every 15 days. Thereafter, failure to reach an appropriate level of heart failure compensation for patients or worsen after two consecutive infusions of study drug or placebo every 15 days, proceed to open the code patient randomization and and apply the most appropriate treatment.
DRUG	Placebo	Patients included in the placebo group receive optimal drug therapy for heart failure and also infusion of placebo at the same infusion rate as levosimendan doses of 0.1 mcg / kg / min for 24 hours every 30 days. Failure to reach an appropriate level of heart failure compensation before the deadline of 30 days for the next study drug administration or placebo, the administration of them will be every 15 days. Thereafter, failure to reach an appropriate level of heart failure compensation for patients or worsen after two consecutive infusions of study drug or placebo every 15 days, proceed to open the code patient randomization and and apply the most appropriate treatment.

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-12-01
• Completion: 2014-12-01
• First posted: 2009-10-02
• Last updated: 2013-09-18

Locations

1 site across 1 country: Spain