Long-Term Intermittent Administration of Levosimendan in Patients With Advanced Heart Failure
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.
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Conditions
Advanced Heart Failure
Intervention
Levosimendan, Placebo
Location
Department of Cardiology. Hospital Universitario de Canarias
La Laguna
S.C. de Tenerife
Spain
38320
Status
Enrolling by invitation
Source
Hospital Universitario de Canarias
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00988806
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Heart Failure
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.
Cardiomegaly
Enlargement of the HEART, usually indicated by a cardiothoracic ratio above 0.50. Heart enlargement may involve the right, the left, or both HEART VENTRICLES or HEART ATRIA. Cardiomegaly is a nonspecific symptom seen in patients with chronic systolic heart failure (HEART FAILURE) or several forms of CARDIOMYOPATHIES.
Heart Failure, Diastolic
Heart failure caused by abnormal myocardial relaxation during DIASTOLE leading to defective cardiac filling.
Heart Failure, Systolic
Heart failure caused by abnormal myocardial contraction during SYSTOLE leading to defective cardiac emptying.
Cardiotonic Agents
Agents that have a strengthening effect on the heart or that can increase cardiac output. They may be CARDIAC GLYCOSIDES; SYMPATHOMIMETICS; or other drugs. They are used after MYOCARDIAL INFARCT; CARDIAC SURGICAL PROCEDURES; in SHOCK; or in congestive heart failure (HEART FAILURE).
Clinical Trials
Levosimendan in High Risk Heart Valve Surgery
Prospective, randomized, double blind study investigating the efficacy of levosimendan in heart failure after cardiac surgery. Study hypothesis: Levosimendan diminishes the need for adren...
The purpose of this study is to evaluate the efficacy of a 24-hour infusion of levosimendan compared with placebo in the treatment of decompensated chronic heart failure.
Study of Blood Concentrations and Physiologic Effects of Levosimendan Given During Heart Surgery
The purpose of this study protocol is to evaluate the blood concentrations of levosimendan when administered at different doses clinically employed during cardiopulmonary bypass or cardiac...
Myocardial Hemodynamic Effects of Levosimendan
This study will test the hypothesis that mechanical efficiency as measured by pressure-volume loop assessment should improve during short-term treatment with intravenous levosimendan....
Renal Effects of Levosimendan in Patients Admitted With Acute Decompensated Heart Failure
The purpose of this study is to evaluate the effect of levosimendan infusion, in addition to standard therapy,on renal function in patients with Acute Heart Failure,compared with standard...
PubMed Articles
Oral levosimendan improves filling pressure and systolic function during long-term treatment.
Abstract Objectives. Oral levosimendan improves ventricular function in short-term clinical trials. The effects of long-term treatment with oral levosimendan were investigated on echocardiographic par...
Acetylation status does not affect levosimendan's hemodynamic effects in heart failure patients.
Abstract Objective. Levosimendan is indicated for acute heart failure. The formation of levosimendan's active metabolite OR-1896 is dependent on the acetylator status. We evaluated whether acetylator...
We report the use of levosimendan in two febrile, neutropenic children with cancer - one post bone marrow transplant - with acute heart failure following chemotherapy. Initial management with epinephr...
To investigate the effects of levosimendan, a positive inotropic agent, on the new heart failure markers immunoglobulin free light chains kappa and lambda (FLC-kappa and FLC-lambda) in decompensated c...
Calcium-sensitizing agents improve cardiac function in acute heart failure; however, their long-term effects on cardiovascular mortality are unknown. We tested the hypothesis that levosimendan, an ino...
