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Peroral Levosimendan in Chronic Heart Failure

Primary Purpose

Chronic Heart Failure, Heart Diseases

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

levosimendan

About this trial

This is an interventional treatment trial for Chronic Heart Failure focused on measuring levosimendan, chronic heart failure, oral administration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Helsinki University Central Hospital

Outcomes

Primary Outcome Measures

Composite endpoint measuring symptoms, morbidity, mortality

Secondary Outcome Measures

Full Information

NCT ID

NCT00130884

First Posted

August 15, 2005

Last Updated

February 19, 2007

Sponsor

Orion Corporation, Orion Pharma

1. Study Identification

Unique Protocol Identification Number

NCT00130884

Brief Title

Peroral Levosimendan in Chronic Heart Failure

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2007

Overall Recruitment Status

Completed

Study Start Date

March 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Orion Corporation, Orion Pharma

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure, Heart Diseases

Keywords

levosimendan, chronic heart failure, oral administration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

300 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

levosimendan

Primary Outcome Measure Information:

Title

Composite endpoint measuring symptoms, morbidity, mortality

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markku S Nieminen, MD

Organizational Affiliation

Helsinki University Central Hospital, Finland

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helsinki University Central Hospital

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

12. IPD Sharing Statement

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Peroral Levosimendan in Chronic Heart Failure

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