NCT01144039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
Last Updated

June 16, 2010

Status Verified

September 1, 2008

Enrollment Period

1.7 years

First QC Date

June 14, 2010

Last Update Submit

June 15, 2010

Conditions

Hypertrophy, Left VentricularAortic StenosisMyocardial IschemiaCardiopulmonary Bypass

Outcome Measures

Primary Outcomes (5)

  • flow propagational velocity

  • Isovolumic relaxation time

  • E-velocity

  • A-velocity

  • E/A ratio

Secondary Outcomes (3)

  • ejection fraction

  • cardiac output

  • mitral ring motion

Interventions

LG-groupDRUG
HG-groupDRUG
Placebo-groupDRUG

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • severe aortic stenosis
  • left ventricular hypertrophy of more than 10mm IVS thickness
  • normal ejection fraction

You may not qualify if:

  • moderately or severely reduced systolic left ventricular function (ejection fraction \<30%)
  • atrial fibrillation or flutter
  • intolerance to glutamate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Hypertrophy, Left VentricularAortic Valve StenosisMyocardial Ischemia

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsAortic Valve DiseaseHeart Valve DiseasesVentricular Outflow ObstructionVascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 14, 2010

First Posted

June 15, 2010

Study Start

February 1, 2006

Primary Completion

November 1, 2007

Study Completion

September 1, 2008

Last Updated

June 16, 2010

Record last verified: 2008-09

Locations

AU(1)