Chronic heart failure MedDRA version: 9.1 Level: LLT Classification code 10008908 Term: Chronic heart failure
Conditions
Interventions
Trade Name: Simdax 2.5 mg/ml
Product Name: Levosimendan
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Levosimendan
CAS Number: 141505-33-1
Concentration unit: mg/ml m
Sponsors
Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with chronic stable heart failure NYHA III and IV diagnosed at least 3 months before inclusion - 6-min.-walk-test 20 years - optimized and individualised neurohormonal background therapy according to ESC-guidelines for the treatment of chronic heart failure. - Patient has signed informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Hospitalization for decompensated heart failure requiring i.v. diuretics within the last month before randomization ? History of torsades des pointes ? Allergy to Levosimendan or any of the excipients ? Administration of inotropes in the last 4 weeks ? Potassium 5,5 mmol/l ? Systolic blood pressure <= 100 mmHg ? Women at childbearing age without using effective contraceptives ( oral contraceptives, intrauterine contraceptive devices) unless surgical sterilisation has been undertaken. ? Female patients who are pregnant or nursing ? Creatinin Clearance < 30ml/min/m2 ? Severe anemia (Hb < 10 mg /dl) ? Mechanical obstruction affecting the ventricular filling or the outflow or both ? Patients with non compliance ? Severe conditions, which make the patient unsuitable to participate in a study as judged by the investigator ? Severe liver disease ? Percutaneous coronary intervention within the last 1 months ? Coronary bypass surgery within the last 3 months ? Planned HTX within the next six months ? Patient involved in another clinical trial ? De-nove heart failure ? Implantation of a cardiac resynchronisation device during the last three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective of the study is to compare the effects of a pulsed application of Levosimendan versus placebo of the composite end-point functional capacity and quality of life.;Secondary Objective: The secondary efficacy objectives are to determine the effects of a pulsed administration of levosimendan on: a) short-term (8 weeks from randomization) and long-term (24 weeks from randomization) event-free survival (cardiac death or heart failure-related hospitalization), b). Components of primary endpoints (6-minute walk test and KCCQ) will be analysed as separate endpoints. Cardiac death will be divided into arrhythmic death and pump failure death. Adjudication of endpoints is assigned to the independent Data Safety and Monitoring Board. The tertiary efficacy objective is to determine theeffect of a pulsed application of levosimendan on: a) marker of inflammatory activation (IL-6, IL-10 and TNF-alpha) b) markers of the apaptotic process (Afas, SFAS, Ligand), c) markers of oxidative stress (MDA, protein carbonyls, nitrotyrosine) d) markers of disease severity (NT-pro-BNP) e) weight f) dose of diuretics g) creatinine clearance and h) cost effectiveness;Primary end point(s): Proporation of patients showing an improvement in the six-minutes walk-testof 20 % or more and 15 % or higher scoring in the Kansas City Cardiomyopathy Questionnaire (KCCQ) at the end of the 28 week study period. | — |
Countries
Austria, Germany, Greece
Outcome results
None listed