Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

Myocardial Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01144039
• Other study ID #: VI_echo_01_2006
• Status: Completed
• Phase: Phase 4
• First received: June 14, 2010
• Last updated: June 15, 2010
• Start date: February 2006
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: September 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Stenosis
• Aortic Valve Stenosis
• Cardiopulmonary Bypass
• Coronary Artery Disease
• Hypertrophy
• Hypertrophy, Left Ventricular
• Myocardial Ischemia

Intervention

Drug:
• LG-group

• HG-group

• Placebo-group

Locations

Country	Name	City	State
Austria	Clin. Dept. of Cardiothoracic and Vascular Anaesthesia & Intensive Medicine, Medical University of Vienna, Vienna General Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	flow propagational velocity			No
Primary	Isovolumic relaxation time			No
Primary	E-velocity			No
Primary	A-velocity			No
Primary	E/A ratio			No
Secondary	ejection fraction			No
Secondary	cardiac output			No
Secondary	mitral ring motion			No