Effect of Heart Rate on Left Ventricular Performance

Sponsor

Hillel Yaffe Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01112176

Collaborator

(none)

100

Enrollment

Location

Duration (Months)

4.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Myocardial Function Myocardial Strain	Procedure: Increase in paced heart rate	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Effect of Heart Rate on Left Ventricular Performance

Study Start Date :

Apr 1, 2010

Anticipated Primary Completion Date :

Apr 1, 2012

Anticipated Study Completion Date :

Apr 1, 2012

Outcome Measures

Primary Outcome Measures

Segmental Strain [approx. 20 minutes]
Segmental Strain by speckle tracking method will be calculated for every stage of each study.

Secondary Outcome Measures

LV function [Approx. 20 minutes]
Parameters of systolic and diastolic function will be calculated at each stage.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hille Yaffe Medical Ceter	Hadera		Israel	38100

Sponsors and Collaborators

Hillel Yaffe Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01112176

Other Study ID Numbers:

013-10-HYMC-CTIL

First Posted:

Apr 28, 2010

Last Update Posted:

Apr 28, 2010

Last Verified:

Apr 1, 2010

Keywords provided by , ,

Strain

Ejection fraction

Diastolic function

Additional relevant MeSH terms:

Sprains and Strains

Study Results

No Results Posted as of Apr 28, 2010