Effect of Bi-ventricular Pacing on Autonomous Nervous System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00190138
Recruitment Status : Unknown
Verified December 2004 by Far Eastern Memorial Hospital.
Recruitment status was:  Not yet recruiting
First Posted : September 19, 2005
Last Update Posted : October 7, 2010
Information provided by:
Far Eastern Memorial Hospital

Brief Summary:
Patients with congestive heart failure are often associated with delayed intraventricular depolarization which causing dyssynchrony and an inefficient pattern of left ventricular contraction. A number of studies have shown that bi-ventricular or left ventricular pacing improves indexes of systolic function as well as decreases sympathetic activation in patients with severe left ventricular systolic dysfunction, dilated cardiomyopathy and a major left-sided intraventricular conduction disorder such as left bundle branch block. One recent study also demonstrated that bi-ventricular pacing can shift heart rate variability (HRV) toward a more favorable profile. Baroreflex sensitivity (BRS) is a measure of the negative feedback properties that interact in modulating the dynamic heart rate and arterial pressure fluctuations. Blunted BRS is found to be associated with an increased risk for both cardiac deaths and arrhythmic events. However, the effect of bi-ventricular pacing on BRS has never been studied. In the present proposal, we plan to measure common hemodynamic parameters, BRS and HRV in a group of heart failure patients receiving open heart surgery in different pacing conditions (bi-ventricular pacing, single LV pacing, single RV pacing). The major aims are to investigate the effect of bi-ventricular pacing on BRS and to clarify the underlying mechanisms.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: Bi-ventricular pacing Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Bi-ventricular Pacing on Autonomous Nervous System

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with normal sinus rhythm proposed to undergo coronary artery bypass surgery.

Exclusion Criteria:

Information from the National Library of Medicine

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Please refer to this study by its identifier (NCT number): NCT00190138

Sponsors and Collaborators
Far Eastern Memorial Hospital
Study Chair: Kuan-Ming Chiu, M.D. Far Eastern Memorial Hospital Identifier: NCT00190138     History of Changes
Other Study ID Numbers: FEMH-93014
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: October 7, 2010
Last Verified: December 2004

Keywords provided by Far Eastern Memorial Hospital:
Bi-ventricular pacing
ventricular resynchronization
baroreflex sensitivity
heart rate variability

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases