The effects of dobutamine on heart function in patients with enlargement of the heart

Phase 1

• Conditions: Aortic stenosisDiastolic dysfunction; MedDRA version: 14.1Level: LLTClassification code 10002907Term: Aortic stenosis & incompetenceSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-001005-27-DK
• Lead Sponsor: Department of Anaesthesiology, University Hospital of Skejby

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-19
• Last Update Posted: 3 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Eligible for operation for aortic stenosis
Normal EF
Left ventrilar hypertrophy
Sinus rythm
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Concomitant bypass operation
Severe mitral valve insufficiency
beta-blockade

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To clarify the hemodynamic effect of low-dose dobutamine on systolic and diastolic cardiac function.;Secondary Objective: Echocardiographic indices of systolic function<br>Echocardiographic indices of diastolic function<br>Mixed venous saturation<br>Heart rate;Primary end point(s): Cardiac index;Timepoint(s) of evaluation of this end point: 0, 90 and 180 minutes

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Echocardiography<br>Invasive measurements.;Timepoint(s) of evaluation of this end point: 0, 90 and 180 minutes