Peroral Levosimendan in Chronic Heart Failure | NCT00130884

Studies
Peroral Levosimendan in Chronic Heart Failure

NCT00130884

Sponsor

Orion Corporation, Orion Pharma

Status

Completed

Last Update Posted

Feb 21, 2007Estimated

Enrollment

300

Phase

Phase 2

Conditions

Chronic Heart Failure
Heart Diseases

Interventions

levosimendan

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Not provided

Completion Date

Mar 2006

First Submitted Date

Aug 15, 2005

First Submission Date that Met QC Criteria

Aug 15, 2005

First Posted Date

Aug 16, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2007

Last Update Posted Date

Feb 21, 2007Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300

Name	Type	Description	Arm Group Labels	Other Names
levosimendan	Drug

Measure	Description	Time Frame
Composite endpoint measuring symptoms, morbidity, mortality

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Markku S Nieminen, MD	Helsinki University Central Hospital, Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki		00029	Finland

ID	Term
D006331	Heart Diseases

ID	Term
D002318	Cardiovascular Diseases

Intervention Browse Module

MeSH Terms

ID	Term
D000077464	Simendan

Ancestor Terms

ID	Term
D006835	Hydrazones
D006834	Hydrazines
D009930	Organic Chemicals
D011724	Pyridazines

Browse Leaves

Not provided

Browse Branches

Not provided