Effect of Heart Rate on Left Ventricular Performance

Myocardial Function Clinical Trial

Official title:

Effect of Heart Rate on Left Ventricular Performance

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01112176
• Other study ID #: 013-10-HYMC-CTIL
• Status: Recruiting
• Phase: N/A
• First received: April 13, 2010
• Last updated: April 27, 2010
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2010
• Source: Hillel Yaffe Medical Center
• Contact: David S. Blondheim, MD
• Phone: 97246304488
• Email: davidb[@]hy.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Myocardial Function
• Myocardial Strain

Intervention

Procedure:
• Increase in paced heart rate
The pacing rate will be increased by 10 bps at every stage

Locations

Country	Name	City	State
Israel	Hille Yaffe Medical Ceter	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Segmental Strain	Segmental Strain by speckle tracking method will be calculated for every stage of each study.	approx. 20 minutes	No
Secondary	LV function	Parameters of systolic and diastolic function will be calculated at each stage.	Approx. 20 minutes	No