Efficacy and safety of pulsed infusions of levosimendan in outpatients with advanced heart failure

• Conditions: Chronic heart failure; MedDRA version: 9.1Level: LLTClassification code 10008908Term: Chronic heart failure

• Registration Number: EUCTR2008-007407-86-GR
• Lead Sponsor: Medizinische Universität Innsbruck - Universitätsklinik für Innere Medizin III

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12-17
• Last Update Posted: 1 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

- Patients with chronic stable heart failure NYHA III and IV diagnosed at least 3 months before inclusion
- 6-min.-walk-test < 350 meters
- EF < 35 %
- age > 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) yes
F.1.3.1 Number of subjects for this age range

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 < 3,5 and >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified