search
Back to results

Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

Primary Purpose

Hypertrophy, Left Ventricular, Aortic Stenosis, Myocardial Ischemia

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
LG-group
HG-group
Placebo-group
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertrophy, Left Ventricular

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

ejection fraction
cardiac output
mitral ring motion

Full Information

First Posted
June 14, 2010
Last Updated
June 15, 2010
Sponsor
Medical University of Vienna
search

1. Study Identification

Unique Protocol Identification Number
NCT01144039
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy, Left Ventricular, Aortic Stenosis, Myocardial Ischemia, Cardiopulmonary Bypass

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
LG-group
Intervention Type
Drug
Intervention Name(s)
HG-group
Intervention Type
Drug
Intervention Name(s)
Placebo-group
Primary Outcome Measure Information:
Title
flow propagational velocity
Title
Isovolumic relaxation time
Title
E-velocity
Title
A-velocity
Title
E/A ratio
Secondary Outcome Measure Information:
Title
ejection fraction
Title
cardiac output
Title
mitral ring motion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Clin. Dept. of Cardiothoracic and Vascular Anaesthesia & Intensive Medicine, Medical University of Vienna, Vienna General Hospital
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

We'll reach out to this number within 24 hrs