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

Study Overview
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Brief Summary
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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.

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

Conditions
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Left Ventricular Hypertrophy, Diastolic Dysfunction, Heart Failure, Heart Rate

Intervention / Treatment
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* Device: Pacemaker


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Left ventricular hypertrophy, Diastolic dysfunction