Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

Glutamate Infusion in Hypertrophied Ventricle After Aortic Valve Replacement - a Randomized Trial

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 Overview

• Status: Completed
• Conditions: Myocardial Ischemia; Aortic Stenosis; Cardiopulmonary Bypass; Hypertrophy, Left Ventricular
• Intervention / Treatment: Drug: LG-group; Drug: HG-group; Drug: Placebo-group

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Clin. Dept. of Cardiothoracic and Vascular Anaesthesia & Intensive Medicine, Medical University of Vienna, Vienna General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
flow propagational velocity
Isovolumic relaxation time
E-velocity
A-velocity
E/A ratio

Secondary Outcome Measures

Outcome Measure
ejection fraction
cardiac output
mitral ring motion

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: February 1, 2006
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: June 14, 2010
• First Submitted That Met QC Criteria: June 14, 2010
• First Posted (Estimate): June 15, 2010

Study Record Updates

• Last Update Posted (Estimate): June 16, 2010
• Last Update Submitted That Met QC Criteria: June 15, 2010
• Last Verified: September 1, 2008

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Cardiomegaly; Myocardial Ischemia; Ischemia; Aortic Valve Stenosis; Hypertrophy; Hypertrophy, Left Ventricular
• Other Study ID Numbers: VI_echo_01_2006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No