The Effects of Dobutamine on Postoperative Cardiac Function in Aortic Valve Replacement

Heart Failure Clinical Trial

Official title:

The Effects of Dobutamine on Postoperative Systolic Deformation and Diastolic Function in Patients With Hypertrophic Cardiomyopathy Operated for Aortic Valve Stenosis

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01375335
• Other study ID #: 1818
• Status: Suspended
• Phase: Phase 4
• First received: June 14, 2011
• Last updated: August 6, 2013
• Start date: June 2011

Study information

• Verified date: August 2013
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

The use of dobutamine in postoperative hemodynamic treatment is widespread despite seemingly intact contraction of the heart. This study aims to elucidate the efficacy of low-dose dobutamine infusion in patients in the postoperative phase replacement of the aortic valve.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• 18-90 years

• Left ventricular posterior wall =/>12mm

• Ejection fraction > 45%

• Sinus rhythm

• Eligible for aortic valve replacement

Exclusion Criteria:

• Need for concomitant cardiac bypass operation.

• Moderate or severe insufficiency of the mitral valve

• Active endocarditis

• Insufficient ultrasound window

• Using B-blockers

• Liver insufficiency

• Patients treated with COMT-inhibitors

• Allergy towards dobutamine

• Pregnancy

• Women of fertile age who do not use relevant anti-conception

• Lacking participant consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Dobutamine
90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized

Locations

Country	Name	City	State
Denmark	Department of Anaesthesia & Intensive Care, Århus University Hospital	Århus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac output	Change in cardiac output (l/min) from initiation of study drug or placebo until 90 minutes of infusion.	From 0 to 90 minutes after drug initiation	No
Secondary	Mean pulmonary artery pressure	Changes in pulmonary artery pressure (mmHg) from start of study drug or placebo infusion until 90 minutes after the start.	From 0 to 90 minutes after drug initiation.	No
Secondary	Echocardiography	Echocardiographic measures of systolic and diastolic heart function.	From 0 minutes to 90 minutes after drug initiation	No
Secondary	Changes in mixed venous saturation	Changes in mixed venous saturation (in per cent) from baseline until the end of dobutrex or placebo infusion.	From 0 minutes to 90 minutes after drug initiation	No
Secondary	norepinephrine requirement	The amount of norepinephrinem(mg) required to maintain adequate systemic blood pressure during the infusion period of dobutrex and placebo	From 0 minutes to 90 minutes after drug initiation	Yes
Secondary	Central venous pressure	Changes in CVP from baseline until 90 minutes of study drug or placebo infusion.	From 0 minutes to 90 minutes after drug initiation	No