advanced chronic heart failure MedDRA version: 9.1 Level: LLT Classification code 10008908 Term: Chronic heart failure
Conditions
Interventions
Trade Name: Simdax
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
University Medical Centre Ljubljana
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age above 18 years 2. At least a 3-month history of advanced heart failure symptoms (NYHA III) 3. Evidence of impaired left ventricular ejection fraction (EF=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Advanced Renal insuficiency (Creatinine clearance of less than 30 ml/min) 2. Advanced liver failure (liver enzymes > 5x ULN) 3. Hipotension (systolic blood pressure 100/min)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the present study is to investigate the effects of levosimendan infusion on conduit vessel stiffness in patients with advanced chronic heart failure.;Secondary Objective: ;Primary end point(s): Augmentation index (as a measure of arterial stiffness) as measured by pulse wave analysis | — |
Countries
Slovenia
Outcome results
None listed