Peroral Levosimendan in Chronic Heart Failure

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.

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Key information

Conditions

Chronic Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Helsinki University Central Hospital

Helsinki, 00029, Finland

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levosimendan

Drug

Primary outcomes

Composite endpoint measuring symptoms, morbidity, mortality

Sponsors and collaborators

Lead sponsor

Orion Corporation, Orion Pharma

Industry

Registry information

Official study title

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

Important dates

Study start: 2005
Study completion: 2006
First posted: Aug 16, 2005
Registry last updated: Feb 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed