THE EFFECTS OF LEVOSIMENDAN ON ARTERIALL STIFFNESS IN PATIENTS WITH ADVANCED CHRONIC HEART FAILURE

Conditions: advanced chronic heart failure
MedDRA version: 9.1Level: LLTClassification code 10008908Term: Chronic heart failure

Registration Number: EUCTR2007-007518-13-SI

Lead Sponsor: niversity Medical Centre Ljubljana

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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<40%) on echocardiography and/or contrast ventriculography
4. Serum creatinine below 350 µmol/l

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) yes
F.1.3.1 Number of subjects for this age range

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 mmHg)
4. Tachycardia (heart rate >100/min)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures