Ambulatory Heart Failure Patients MedDRA version: 20.0 Level: LLT Classification code 10074631 Term: Systolic heart failure System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Simdax
Product Name: Simdax
Pharmaceutical Form: Concentrate and solvent for concentrate for solution for infusion
Pharmaceutical form of the placebo: Concentrate for concentrate for solut
Sponsors
Uniwersytet Medyczny w Bialymstoku
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years • Heart failure with left ventricular ejection fraction = 35% • Hospitalization for worsening heart failure within the last 6 months • NYHA functional class III or outpatient IV • Optimal Medical Therapy (OMT) according to ESC guidelines, established as stable for at least 1 month before randomization, according to the knowledge and experience of the qualifying clinician • Distance covered in the 6-minute walk 6MWT =65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: • The etiology of heart failure that can be associated with restrictive cardiomyopathy or with hypertrophic cardiomyopathy or with uncorrected severe valvular disease according to the AHA / ACC / ESC criteria (Note: functional mitral valve insufficiency found on echocardiography does not exclude participation in the study) or heart failure with a probable reversible cause (tachyarrhythmic, alcohol, etc.) • Hypotension with symptoms of tissue hypoperfusion (systolic blood pressure 2 mmol / L - 'cold-wet' hemodynamic profile) • Uncontrolled hypertension • Planned revascularization or other surgical treatment of heart failure within the next 12 months (except for qualification or waiting for mechanical circulatory support or heart transplantation) • Advanced chronic kidney disease (eGFR 5 upper limit of the reference normal level of hepatic transaminases and / or> 3 upper limit of the reference limit of total bilirubin concentration) • Severe chronic lung disease with features of respiratory failure [defined as disorders of the respiratory system impairing gas exchange and leading to hypoxemia - arterial oxygen partial pressure (PaO2) 55%)]. • Accompanying chronic diseases with poor prognosis (e.g. cancer) • Paroxysmal supraventricular tachycardia, paroxysmal ventricular tachycardia including torsade de pointes, advanced atrioventricular blocks in the month prior to study screening visit • History of hypersensitivity to levosimendan • Pregnancy or the postpartum period • A patient with predictable problems with cooperation with the medical and nursing team
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effectiveness of repeated infusions of levosimendan in outpatients with advanced systolic HF in the prevention of death and recurrent hospitalizations.;Secondary Objective: Not applicable;Primary end point(s): Primary endpoint: death OR unplanned hospitalization due to heart failure (according to ICD-10: I50, R57.0), assessed jointly, depending on what occurs earlier in the 12-month follow-up.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Death from any cause; • Death from cardiovascular causes (according to ICD-10: the whole group I00-I99); • Unplanned hospitalization for heart failure; • All-cause death OR unscheduled hospitalization for heart failure at the 12-18 month and 0-18 month time points; • Death from cardiovascular causes OR unplanned hospitalization for heart failure; • Implantation of a mechanical circulatory support system (according to ICD-9-CM: 37.62, 37.66); • Heart transplantation or implantation of a system that completely replaces the heart function (according to ICD-9- CM: 37.51, 37.52, 33.6); • Implantation of a mechanical circulatory support system or heart transplant or implantation of a system that completely replaces the work of the heart; • Time to the first unscheduled hospitalization for heart failure in the subgroup of unplanned hospitalization for heart failure; • Time to implantation of a mechanical circulatory support system, heart transplantation or implantation of a system that completely replaces the work of the heart; • Percentage of patients who returned to levosimendan / placebo infusions in the 13th to 18th month phase of the study; • Quality of life (QoL) assessed using the KCCQ questionnaire; • Distance in meters covered in the 6-minute walk 6MWT test; • NTproBNP concentration; • eGFR according to CDK-EPI; • Selected echocardiographic parameters.;Timepoint(s) of evaluation of this end point: Assessed in the following windows: 0-12 months, 12-18 months oraz 0-18 months | — |
Countries
Poland
Contacts
Public ContactBiuro Transferu Technologii
Uniwersytet Medyczny w Bialymstoku
Outcome results
None listed