Peroral Levosimendan in Chronic Heart Failure

Effects of Peroral Levosimendan in the Prevention of Further Hospitalisations in Patients With Chronic Heart Failure. A Randomised, Phase II, Double-Blind, Placebo-Controlled, Multi-Centre, Parallel-Group Study

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00130884

Enrollment

300

Registered

2005-08-16

Start date

2005-03-31

Completion date

2006-03-31

Last updated

2007-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Heart Failure, Heart Diseases

Keywords

levosimendan, chronic heart failure, oral administration

Brief summary

The study will investigate the efficacy of oral levosimendan in patients with chronic New York Heart Association (NYHA) IIIb-IV heart failure (HF) using a composite end-point evaluating patient symptoms, morbidity and mortality. The patients are on treatment for at least 6 months.

Detailed description

The patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.

Interventions

DRUGlevosimendan

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Diagnosed chronic heart failure * Severe symptoms (NYHA IIIb-IV) * Optimal on-going oral treatment for HF * Left ventricular ejection fraction less than or equal to 30%

Exclusion criteria

* Severe obstruction of ventricular outflow tracts * Acute myocardial infarction within 30 days before screening * Cardiac surgery or coronary angioplasty within 30 days before screening

Design outcomes

Primary

Measure	Time frame
Composite endpoint measuring symptoms, morbidity, mortality	—

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026