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Peroral Levosimendan in Chronic Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00130884
First Posted: August 16, 2005
Last Update Posted: February 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Orion Corporation, Orion Pharma
  Purpose
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.

Condition Intervention Phase
Chronic Heart Failure Heart Diseases Drug: levosimendan Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Composite endpoint measuring symptoms, morbidity, mortality

Estimated Enrollment: 300
Study Start Date: March 2005
Estimated Study Completion Date: March 2006
Detailed Description:
The patients are randomised to 3 groups; higher or lower levosimendan dose group or placebo.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00130884


Locations
Finland
Helsinki University Central Hospital
Helsinki, Finland, 00029
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Investigators
Principal Investigator: Markku S Nieminen, MD Helsinki University Central Hospital, Finland
  More Information

ClinicalTrials.gov Identifier: NCT00130884     History of Changes
Other Study ID Numbers: 3001081
First Submitted: August 15, 2005
First Posted: August 16, 2005
Last Update Posted: February 21, 2007
Last Verified: February 2007

Keywords provided by Orion Corporation, Orion Pharma:
levosimendan
chronic heart failure
oral administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs