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Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01144039
First received: June 14, 2010
Last updated: June 15, 2010
Last verified: September 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Glutamate Infusion in Hypertrophied Ventricle After Aortic Valve Replacement - a Randomized Trial

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • flow propagational velocity [ Designated as safety issue: No ]
  • Isovolumic relaxation time [ Designated as safety issue: No ]
  • E-velocity [ Designated as safety issue: No ]
  • A-velocity [ Designated as safety issue: No ]
  • E/A ratio [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ejection fraction [ Designated as safety issue: No ]
  • cardiac output [ Designated as safety issue: No ]
  • mitral ring motion [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: February 2006
Study Completion Date: September 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01144039

Locations
Austria
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01144039     History of Changes
Other Study ID Numbers: VI_echo_01_2006
Study First Received: June 14, 2010
Last Updated: June 15, 2010
Health Authority: Austria: Austrian Federal Office for Safety in Health Care

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

ClinicalTrials.gov processed this record on November 25, 2014