Effect of Heart Rate on Left Ventricular Performance

April 27, 2010 updated by: Hillel Yaffe Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Recruiting
        • Hille Yaffe Medical Ceter
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Segmental Strain
Time Frame: approx. 20 minutes
Segmental Strain by speckle tracking method will be calculated for every stage of each study.
approx. 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LV function
Time Frame: Approx. 20 minutes
Parameters of systolic and diastolic function will be calculated at each stage.
Approx. 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: David S. Blondheim, MD, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ANTICIPATED)

April 1, 2012

Study Completion (ANTICIPATED)

April 1, 2012

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (ESTIMATE)

April 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 28, 2010

Last Update Submitted That Met QC Criteria

April 27, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 013-10-HYMC-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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