Peroral Levosimendan in Chronic Heart Failure

NCT ID: NCT00130884

Last Updated: 2007-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-03-31

Brief Summary

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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

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

Conditions

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Chronic Heart Failure Heart Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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levosimendan

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orion Corporation, Orion Pharma

INDUSTRY

Sponsor Role lead

Principal Investigators

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Markku S Nieminen, MD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital, Finland

Locations

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Helsinki University Central Hospital

Helsinki, , Finland

Site Status

Countries

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Finland

Other Identifiers

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3001081

Identifier Type: -

Identifier Source: org_study_id

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