Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01144039
Recruitment Status : Completed
First Posted : June 15, 2010
Last Update Posted : June 16, 2010
Information provided by:
Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
Hypertrophy, Left Ventricular Aortic Stenosis Myocardial Ischemia Cardiopulmonary Bypass Drug: LG-group Drug: HG-group Drug: Placebo-group Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Glutamate Infusion in Hypertrophied Ventricle After Aortic Valve Replacement - a Randomized Trial
Study Start Date : February 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : September 2008

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U.S. FDA Resources

Primary Outcome Measures :
  1. flow propagational velocity
  2. Isovolumic relaxation time
  3. E-velocity
  4. A-velocity
  5. E/A ratio

Secondary Outcome Measures :
  1. ejection fraction
  2. cardiac output
  3. mitral ring motion

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01144039

Clin. Dept. of Cardiothoracic and Vascular Anaesthesia & Intensive Medicine, Medical University of Vienna, Vienna General Hospital
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna Identifier: NCT01144039     History of Changes
Other Study ID Numbers: VI_echo_01_2006
First Posted: June 15, 2010    Key Record Dates
Last Update Posted: June 16, 2010
Last Verified: September 2008

Additional relevant MeSH terms:
Myocardial Ischemia
Coronary Artery Disease
Aortic Valve Stenosis
Hypertrophy, Left Ventricular
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Heart Valve Diseases
Ventricular Outflow Obstruction
Pathological Conditions, Anatomical