Effect of Heart Rate on Left Ventricular Performance

NCT ID: NCT01112176

Last Updated: 2010-04-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-04-30

Brief Summary

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The current study is aimed at determining the normal response to increasing heart rates. For this purpose, atrial pacing will be used to increase heart rate.

Detailed Description

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Participants will be patients with pacemakers and normal A-V node conduction with a possibility for right atrial pacing mode.

Detailed Echo studies will be performed at baseline. Echo studies will be repeated at each pacing stage, stages defined as 10 bpm increments in paced heart rate. Each stage will last 2-3 min or as long as it takes to record the echo study. Heart rate will be increased to 85% of predicted heart rate for age or at to appearance of signs of ischemia.

Hemodynamic parameters will be recorded and segmental longitudinal strain will be calculated (as well as other Echo data), for each stage.

Conditions

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Myocardial Function Myocardial Strain

Keywords

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Strain Ejection fraction Diastolic function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Interventions

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Increase in paced heart rate

The pacing rate will be increased by 10 bps at every stage

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients with AAI or DDD pacemaker with intact AV nodal conduction that can be set to work in AAI mode.
2. Stable rhythm (either sinus or paced).
3. Good quality baseline echo.
4. Able and willing to sign Informed Consent Form.

Exclusion Criteria

1. Prior heart failure or ischemic heart disease.
2. Severe valvular lesions.
3. Severe pulmonary hypertension.
4. Known intolerance to rapid pacing.
5. Multiple extrasystoles (more than 1 per echo or monitor screen).
6. Age over 70.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Hillel Yaffe Medical Center

Principal Investigators

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David S. Blondheim, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hille Yaffe Medical Ceter

Hadera, Israel, Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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David S. Blondheim, MD

Role: CONTACT

Phone: 97246304488

Email: [email protected]

David S. Blondheim, MD

Role: CONTACT

Facility Contacts

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David Blondheim, MD

Role: primary

Other Identifiers

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013-10-HYMC-CTIL

Identifier Type: -

Identifier Source: org_study_id