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Effect of Heart Rate on Left Ventricular Performance

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01112176
First Posted: April 28, 2010
Last Update Posted: April 28, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hillel Yaffe Medical Center
  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: None (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 ]
    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 ]
    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:
    Procedure: Increase in paced heart rate
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 13, 2010
First Posted: April 28, 2010
Last Update Posted: April 28, 2010
Last Verified: April 2010

Keywords provided by Hillel Yaffe Medical Center:
Strain
Ejection fraction
Diastolic function

Additional relevant MeSH terms:
Sprains and Strains
Wounds and Injuries