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OpenTrials
Completed

NCT Number: NCT01144039

Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair

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.

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Key information

Conditions

Hypertrophy, Left Ventricular Aortic Stenosis Aortic Valve Disease Aortic Valve Stenosis Cardiomegaly Cardiopulmonary Bypass Cardiovascular Diseases Heart Diseases Heart Valve Diseases Hypertrophy Myocardial Ischemia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Vascular Diseases Ventricular Outflow Obstruction

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LG-group

Drug

HG-group

Drug

Placebo-group

Drug

Primary outcomes

  1. flow propagational velocity

  2. Isovolumic relaxation time

  3. E-velocity

  4. A-velocity

  5. E/A ratio

Secondary outcomes

  1. ejection fraction

  2. cardiac output

  3. mitral ring motion

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2008
First posted
Jun 15, 2010
Registry last updated
Jun 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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