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Effect of Heart Rate on Left Ventricular Performance

Primary Purpose

Myocardial Function, Myocardial Strain

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Increase in paced heart rate

About this trial

This is an interventional basic science trial for Myocardial Function focused on measuring Strain, Ejection fraction, Diastolic function

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hille Yaffe Medical CeterRecruiting

Outcomes

Primary Outcome Measures

Segmental Strain

Segmental Strain by speckle tracking method will be calculated for every stage of each study.

Secondary Outcome Measures

LV function

Parameters of systolic and diastolic function will be calculated at each stage.

Full Information

NCT ID

NCT01112176

First Posted

April 13, 2010

Last Updated

April 27, 2010

Sponsor

Hillel Yaffe Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01112176

Brief Title

Effect of Heart Rate on Left Ventricular Performance

Official Title

Effect of Heart Rate on Left Ventricular Performance

Study Type

Interventional

2. Study Status

Record Verification Date

April 2010

Overall Recruitment Status

Unknown status

Study Start Date

April 2010 (undefined)

Primary Completion Date

April 2012 (Anticipated)

Study Completion Date

April 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Myocardial Function, Myocardial Strain

Keywords

Strain, Ejection fraction, Diastolic function

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

Increase in paced heart rate

Intervention Description

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

Primary Outcome Measure Information:

Title

Segmental Strain

Description

Segmental Strain by speckle tracking method will be calculated for every stage of each study.

Time Frame

approx. 20 minutes

Secondary Outcome Measure Information:

Title

LV function

Description

Parameters of systolic and diastolic function will be calculated at each stage.

Time Frame

Approx. 20 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David S. Blondheim, MD

Phone

97246304488

davidb@hy.health.gov.il

First Name & Middle Initial & Last Name or Official Title & Degree

David S. Blondheim, MD

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David S. Blondheim, MD

Organizational Affiliation

Hillel Yaffe Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hille Yaffe Medical Ceter

City

Hadera

ZIP/Postal Code

38100

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Blondheim, MD

Phone

97246304488

davidb@hy.health.gov.il

First Name & Middle Initial & Last Name & Degree

David S. Blondheim, MD

12. IPD Sharing Statement

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Effect of Heart Rate on Left Ventricular Performance

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