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

NCT ID: NCT01241838

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-08-31

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.

Detailed Description

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Conditions

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Left Ventricular Hypertrophy Diastolic Dysfunction Heart Failure Heart Rate

Keywords

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Heart failure Left ventricular hypertrophy Diastolic dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Normal left ventricular size

Postoperative patient with normal left ventricular size

Group Type PLACEBO_COMPARATOR

Pacemaker

Intervention Type DEVICE

Routine postoperative temporary pacemaker Rate change of 65-80-95-110-125 beats/second in random order at day 3-4 after operation

Left ventricular hypertrophy

Postoperative patient with left ventricular hypertrophy

Group Type ACTIVE_COMPARATOR

Pacemaker

Intervention Type DEVICE

Routine postoperative temporary pacemaker Rate change of 65-80-95-110-125 beats/second in random order at day 3-4 after operation

Interventions

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Pacemaker

Routine postoperative temporary pacemaker Rate change of 65-80-95-110-125 beats/second in random order at day 3-4 after operation

Intervention Type DEVICE

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Juhl-Olsen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, Århus University Hospital

Locations

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Department of Anaesthesiology, Århus University Hospital

Århus N, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1717

Identifier Type: -

Identifier Source: org_study_id