NCT00219388

Brief Summary

The purpose of this study is to compare the effects of levosimendan with dobutamine on heart function in patients suffering of severe chronic heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 heart-failure

Timeline
Completed

Started Nov 2002

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

November 1, 2002

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

March 20, 2017

Status Verified

September 1, 2005

First QC Date

September 14, 2005

Last Update Submit

March 17, 2017

Conditions

Heart Failure

Keywords

SafetyEfficacyLevosimendanDobutamineIntravenousInvasive hemodynamicsDecompensated Heart Failure

Outcome Measures

Primary Outcomes (1)

  • Compare the hemodynamic parameters Cardiac Index (CI) and Pulmonary Capillary Wedge Pressure (PCWP) from baseline to 24 hours, between the two groups.

Secondary Outcomes (8)

  • Compare the efficacy and safety between the treatment groups, with regard to:

  • • Changes in hemodynamic parameters from baseline to 24 and 48 hours.

  • • Change in study subject's and investigator's assessment of symptoms of heart failure at 48 hours and 1-month follow-up.

  • • Change in New York Heart Association (NYHA) classat 48 hours and 1-month follow-up.

  • • Ability to continue treatment with β-receptor blocking agents.

  • +3 more secondary outcomes

Interventions

LevosimendanDRUG

Eligibility Criteria

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

You may qualify if:

  • Decompensated chronic heart failure of ischemic or non-ischemic origin, in NYHA class III to IV, despite optimised conventional treatment and who may benefit from intravenous positive inotropic agents as per the investigator's judgment.
  • Ongoing treatment with a beta-receptor blocking agent in a stable regimen for at least 3 months and at an optimal dose as per the investigator's judgment.
  • Left ventricular (LV) ejection fraction (EF) less than or similar to 35%.
  • CI \< 2.5 l/min/m2.
  • Mean PCWP \>15 mmHg.

You may not qualify if:

  • Significant mechanical obstruction affecting ventricular filling and/or outflow.
  • Systolic blood pressure 85 mmHg or less at screening and/or baseline.
  • Heart rate 130 bpm or greater, persistent for at least 5 minutes at screening and/or baseline.
  • Severe angina pectoris during the 6 hours before screening and/or baseline.
  • Deterioration of chronic heart failure due to an acute myocardial infarction within 5 days before screening measurements.
  • Administration of Simdax within 1 month before baseline.
  • A history of Torsades de Pointes.
  • Evidence of severe renal insufficiency (serum creatinine \> 450 μmol/l or on dialysis) at screening.
  • Significant hepatic impairment or elevation of liver enzymes to 5 times the upper limit of normal range of the analysing laboratory at screening.
  • Acute bleeding or severe anaemia.
  • Heart surgery within 3 months before baseline.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department, Sahlgrenska University Hospital

Gothenburg, 413 45, Sweden

Location

Related Publications (1)

  • Follath F, Cleland JG, Just H, Papp JG, Scholz H, Peuhkurinen K, Harjola VP, Mitrovic V, Abdalla M, Sandell EP, Lehtonen L; Steering Committee and Investigators of the Levosimendan Infusion versus Dobutamine (LIDO) Study. Efficacy and safety of intravenous levosimendan compared with dobutamine in severe low-output heart failure (the LIDO study): a randomised double-blind trial. Lancet. 2002 Jul 20;360(9328):196-202. doi: 10.1016/s0140-6736(02)09455-2.

    PMID: 12133653BACKGROUND

MeSH Terms

Conditions

Heart Failure

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Claes-Håkan Bergh, Assoc Prof

    Institution of Cardiology, Sahlgrenska University Hospital, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 22, 2005

Study Start

November 1, 2002

Study Completion

April 1, 2005

Last Updated

March 20, 2017

Record last verified: 2005-09

Locations

SE(1)