Inotropic Treatment With Levosimendan (SimdaxR)in Heart Surgery

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01221116

Enrollment

Registered

2010-10-14

Start date

2003-01-31

Completion date

2008-12-31

Last updated

2010-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Heart Failure

Keywords

coronary artery disease,, aortic stenosis,, heart failure

Brief summary

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

Detailed description

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

Interventions

DRUGlevosimendan

levosimendan 0.1 microgram/kg/min) for 24 hours

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* EF (ejection fraction)\<40%

Exclusion criteria

* renal failure, liver failure

Design outcomes

Primary

Measure	Time frame
Need for inotropic agents or IABP (intra aortal balloon pump)	jan 2003 - dec 2008

Secondary

Measure	Time frame
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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026