The Effect of Heart Rate on Cardiac Index in Patients With Left Ventricular Hypertrophy

Not Applicable

Terminated

• Conditions: Left Ventricular Hypertrophy; Diastolic Dysfunction; Heart Failure; Heart Rate
• Interventions: Device: Pacemaker

• Registration Number: NCT01241838
• Lead Sponsor: University of Aarhus

Brief Summary

The purpose of this study is to compare the effect of heart rate on cardiac index in patients with or without left ventricular hypertrophy. The study will be conducted in postoperative heart surgery patients with a pacemaker.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-11-15
• Study First Submitted QC: 2010-11-15
• Study First Posted: 2010-11-16
• Study Start: 2011-02
• Status Verified: 2012-08
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Last Update Submitted: 2012-08-03
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• Scheduled heart surgery including thoracotomy
• Ejection fraction > 45%
• Duration of QRS complex < 120 milliseconds
• Sinus rhythm
• Planned perioperative temporary pacemaker

Group: Left ventricular hypertrophy:

Thickness of interventricular septum and posterior wall >11 mm.

Group: No left ventricular hypertrophy:

Thickness of interventricular septum and posterior wall <11 mm.

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Exclusion Criteria

• Active endocarditis
• Severe mitral insufficiency
• No patient consent

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal left ventricular size	Pacemaker	Postoperative patient with normal left ventricular size
Left ventricular hypertrophy	Pacemaker	Postoperative patient with left ventricular hypertrophy

Primary Outcome Measures

Name	Time	Method
Cardiac index	At heart rates 65-80-95-110-125

Secondary Outcome Measures

Name	Time	Method
Mean arterial blood pressure	At heart rates 65-80-95-110-125
Ejection fraction	Heart rates of 65-80-95-110-120	Echocardiographic index of systolic function
Strain	Heart rates of 65-80-95-110-125	Echocardiographic index of systolic function
S-max	Heart rates of 65-80-95-110-125 beats per second	Echocardiographic index of systolic function
E/E'	Heart rates of 65-80-95-110-125 beats per second	Echocardiographic index of diastolic function
E/A ratio	Heart rates of 65-80-95-110-125 beats per second	Echocardiographic index of diastolic function
E'/A' ratio	Heart rates of 65-80-95-110-125 beats per second	Echocardiographic index of diastolic function
Isovolumetric relaxation index	Heart rates of 65-80-95-110-125 beats per second	Echocardiographic index of diastolic function
IVRT/IVRT'	Heart rates of 65-80-95-110-125 beats per second	Echocardiographic index of diastolic function
End diastolic volume	Heart rates of 65-80-95-110-125 beats per second	Volume of left ventricle and end diastole
End systolic volume	Heart rates of 65-80-95-110-125 beats per second	Volume of left ventricle at end systole

Trial Locations

Locations (1)

Department of Anaesthesiology, Århus University Hospital; 🇩🇰 Århus N, Denmark