Effect of Heart Rate on Left Ventricular Performance | NCT01112176

Studies
Effect of Heart Rate on Left Ventricular Performance

NCT01112176

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Apr 28, 2010Estimated

Enrollment

100Estimated

Phase

Not Applicable

Conditions

Myocardial Function
Myocardial Strain

Interventions

Increase in paced heart rate

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2010

Primary Completion Date

Apr 2012Estimated

Completion Date

Apr 2012Estimated

First Submitted Date

Apr 13, 2010

First Submission Date that Met QC Criteria

Apr 27, 2010

First Posted Date

Apr 28, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2010

Last Update Posted Date

Apr 28, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Increase in paced heart rate	Procedure	The pacing rate will be increased by 10 bps at every stage

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
David S. Blondheim, MD	Contact	97246304488		davidb@hy.health.gov.il
David S. Blondheim, MD	Contact

Overall Officials

Name	Affiliation	Role
David S. Blondheim, MD	Hillel Yaffe Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hille Yaffe Medical Ceter	Recruiting	Hadera	Israel	38100	Israel

Condition Browse Module

MeSH Terms

ID	Term
D013180	Sprains and Strains

Ancestor Terms

ID	Term
D014947	Wounds and Injuries

Browse Leaves

Not provided

Browse Branches

Not provided