Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

Heart Failure Clinical Trial

Official title:

Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01221116
• Other study ID #: INSI-study
• Status: Terminated
• Phase: N/A
• First received: October 13, 2010
• Last updated: November 1, 2010
• Start date: January 2003
• Est. completion date: December 2008

Study information

• Verified date: January 2003
• Source: Ullevaal University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• EF (ejection fraction)<40%

Exclusion Criteria:

• renal failure, liver failure

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Surgery
• Heart Failure

Intervention

Drug:
• levosimendan
levosimendan 0.1 microgram/kg/min) for 24 hours

Locations

Country	Name	City	State
Norway	Dept. of Cardiothoracic Anesthesia, Ullevål University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Need for inotropic agents or IABP (intra aortal balloon pump)		jan 2003 - dec 2008	No
Secondary	Biochemical, echocardiographic data, Gated SPECT (single photon emission gated tomography) data, laser Doppler data, 24 hour ECG (electrocardiogram) data and clinical "all round" data.		jan 2003-dec 2008	No