Peroral Levosimendan in Chronic Heart Failure

Orion Corporation, Orion Pharma300 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Chronic Heart Failure Heart Diseases

Interventions

levosimendanDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Helsinki University Central Hospital

Helsinki, Finland

Outcomes

Primary Outcomes

Composite endpoint measuring symptoms, morbidity, mortality

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.