Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

This study has been terminated.
(The study was stopped due to difficulties in including patients)
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT01221116
First received: October 13, 2010
Last updated: November 1, 2010
Last verified: January 2003
  Purpose

Hypothesis: Treatment with levosimendan will preserve myocardial function and hemodynamics after cardiac surgery and lead to reduced stay at intensive care unit


Condition Intervention
Heart Failure
Cardiac Surgery
Drug: levosimendan

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Need for inotropic agents or IABP (intra aortal balloon pump) [ Time Frame: jan 2003 - dec 2008 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data. [ Time Frame: jan 2003-dec 2008 ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: January 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1: Type of surgery
Two types of patients are compared (placebo vs levosimendan): CABG - coronary artery bypass grafting and AVR - aortic valve replacement (either with or without CABG - coronary artery bypass grafting)
Drug: levosimendan
levosimendan 0.1 microgram/kg/min) for 24 hours
Other Name: Type of surgery

Detailed Description:

Single center, prospective, randomized parallel-group, double-blinded study

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • EF (ejection fraction)<40%

Exclusion Criteria:

  • renal failure, liver failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01221116

Locations
Norway
Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: Knut A Kirkebøen, MD, PhD Ullevaal University Hospital
  More Information

No publications provided

Responsible Party: Ullevaal University Hospital, Knut Arvid Kirkebøen
ClinicalTrials.gov Identifier: NCT01221116     History of Changes
Other Study ID Numbers: INSI-study
Study First Received: October 13, 2010
Last Updated: November 1, 2010
Health Authority: Norway: Norwegian Medicines Agency

Keywords provided by Ullevaal University Hospital:
coronary artery disease,
aortic stenosis,
heart failure

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Simendan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Cardiotonic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014