NCT00130884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 16, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
Last Updated

February 21, 2007

Status Verified

February 1, 2007

First QC Date

August 15, 2005

Last Update Submit

February 19, 2007

Conditions

Chronic Heart FailureHeart Diseases

Keywords

levosimendanchronic heart failureoral administration

Outcome Measures

Primary Outcomes (1)

  • Composite endpoint measuring symptoms, morbidity, mortality

Interventions

levosimendanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • Severe obstruction of ventricular outflow tracts
  • Acute myocardial infarction within 30 days before screening
  • Cardiac surgery or coronary angioplasty within 30 days before screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helsinki University Central Hospital

Helsinki, 00029, Finland

Location

MeSH Terms

Conditions

Heart Diseases

Interventions

Simendan

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Markku S Nieminen, MD

    Helsinki University Central Hospital, Finland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 15, 2005

First Posted

August 16, 2005

Study Start

March 1, 2005

Study Completion

March 1, 2006

Last Updated

February 21, 2007

Record last verified: 2007-02

Locations

FI(1)