Status:
TERMINATED
Effects of Levosimendan in Patients Eligible for Aortic Valve Replacement With Left Ventricular Hypertrophy
Lead Sponsor:
University of Aarhus
Conditions:
Diastolic Dysfunction
Left Ventricular Hypertrophy
Eligibility:
All Genders
30-90 years
Phase:
PHASE4
Brief Summary
This is a clinical, randomised, double-blinded study in which patients eligible for aortic valve replacement are enrolled. Patients receive infusion of either levosimendan or placebo 4 hours prior to ...
Detailed Description
Levosimendan or placebo will be infusion for approximately 4 hours prior to aortic valve replacement in patients with severe hypertrophy of the left ventricle and echocardiographic signs of diastolic ...
Eligibility Criteria
Inclusion
- Eligible for aortic valve replacement
- EF \> 45%
- Left ventricular posterior wall \> 12mm
- Sinus rhythm
Exclusion
- Concomitant bypass operation
- Severe mitral insufficiency
- Active endocarditis
- Insufficient ultrasound opportunity
- Systolic blood pressure \< 100 mmHg
- moderate-severe renal failure
- allergy to levosimendan
- lack of patient consent Pregnancy or status of lactating
- Fertile women who do not use relevant anticonception
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01188369
Start Date
September 1 2010
End Date
March 1 2013
Last Update
December 3 2018
Active Locations (1)
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1
Department of Anaesthesiology
Århus N, Central Jutland, Denmark, 8200