Brief Title
Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair
Official Title
Glutamate Infusion in Hypertrophied Ventricle After Aortic Valve Replacement - a Randomized Trial
Brief Summary
Purpose: The effect of intravenous glutamate infusion on myocardial diastolic function and overall hemodynamics were studied in patients undergoing elective aortic valve replacement with severe aortic stenosis and associated left ventricular hypertrophy . Methods: 25 patients will be included in this double-blind randomized placebo-controlled study. Glutamate was administered intravenously immediately after aortic cross-clamp release. The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1 h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal echocardiography (TEE) is used to measure diastolic and systolic ventricular function before sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally routine hemodynamic parameters are measured intraoperatively.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
flow propagational velocity
Secondary Outcome
ejection fraction
Condition
Hypertrophy, Left Ventricular
Intervention
LG-group
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
27
Start Date
February 2006
Completion Date
September 2008
Primary Completion Date
November 2007
Eligibility Criteria
Inclusion Criteria: - severe aortic stenosis - left ventricular hypertrophy of more than 10mm IVS thickness - normal ejection fraction - SR Exclusion Criteria: - moderately or severely reduced systolic left ventricular function (ejection fraction <30%) - atrial fibrillation or flutter - intolerance to glutamate.
Gender
All
Ages
19 Years - 90 Years
Accepts Healthy Volunteers
No
Contacts
, ,
Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT01144039
Organization ID
VI_echo_01_2006
Study Sponsor
Medical University of Vienna
Study Sponsor
, ,
Verification Date
September 2008