Effect of Heart Rate on Left Ventricular Performance

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2010 by Hillel Yaffe Medical Center.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Hillel Yaffe Medical Center

ClinicalTrials.gov Identifier:

NCT01112176

First received: April 13, 2010

Last updated: April 27, 2010

Last verified: April 2010

History of Changes

Purpose

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.

Condition	Intervention
Myocardial Function Myocardial Strain	Procedure: Increase in paced heart rate

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Official Title:	Effect of Heart Rate on Left Ventricular Performance

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:

Segmental Strain [ Time Frame: approx. 20 minutes ] [ Designated as safety issue: No ]
Segmental Strain by speckle tracking method will be calculated for every stage of each study.

Secondary Outcome Measures:

LV function [ Time Frame: Approx. 20 minutes ] [ Designated as safety issue: No ]
Parameters of systolic and diastolic function will be calculated at each stage.

Estimated Enrollment:	100
Study Start Date:	April 2010
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112176

Contacts

Contact: David S. Blondheim, MD	97246304488	davidb@hy.health.gov.il
Contact: David S. Blondheim, MD

Locations

Israel
Hille Yaffe Medical Ceter	Recruiting
Hadera, Israel, 38100
Contact: David Blondheim, MD 97246304488 davidb@hy.health.gov.il
Principal Investigator: David S. Blondheim, MD

Sponsors and Collaborators

Hillel Yaffe Medical Center

Investigators

Principal Investigator:

David S. Blondheim, MD

Hillel Yaffe Medical Center

More Information

No publications provided

Responsible Party:	David S. Blondheim, MD, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:	NCT01112176 History of Changes
Other Study ID Numbers:	013-10-HYMC-CTIL
Study First Received:	April 13, 2010
Last Updated:	April 27, 2010
Health Authority:	Israel: Ministry of Health

Keywords provided by Hillel Yaffe Medical Center:

Strain
Ejection fraction
Diastolic function

ClinicalTrials.gov processed this record on May 16, 2013

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