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

August 3, 2012 updated by: University of Aarhus
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Århus N, Denmark, 8200
        • Department of Anaesthesiology, Århus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

28 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Exclusion Criteria:

  • Active endocarditis
  • Severe mitral insufficiency
  • No patient consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Normal left ventricular size
Postoperative patient with normal left ventricular size
Device: Pacemaker
Routine postoperative temporary pacemaker Rate change of 65-80-95-110-125 beats/second in random order at day 3-4 after operation
Active Comparator: Left ventricular hypertrophy
Postoperative patient with left ventricular hypertrophy
Device: Pacemaker
Routine postoperative temporary pacemaker Rate change of 65-80-95-110-125 beats/second in random order at day 3-4 after operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac index
Time Frame: At heart rates 65-80-95-110-125
At heart rates 65-80-95-110-125

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Principal Investigator: Peter Juhl-Olsen, M.D., Department of Anaesthesiology, Århus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 15, 2010

First Posted (Estimate)

November 16, 2010

Study Record Updates

Last Update Posted (Estimate)

August 6, 2012

Last Update Submitted That Met QC Criteria

August 3, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1717

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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