Effect of Bi-ventricular Pacing on Autonomous Nervous System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by Far Eastern Memorial Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00190138
First received: September 12, 2005
Last updated: October 5, 2010
Last verified: December 2004
  Purpose

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 Intervention
Congestive Heart Failure
Device: Bi-ventricular pacing

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Bi-ventricular Pacing on Autonomous Nervous System

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00190138

Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Study Chair: Kuan-Ming Chiu, M.D. Far Eastern Memorial Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00190138     History of Changes
Other Study ID Numbers: FEMH-93014, Femh-93-C-014
Study First Received: September 12, 2005
Last Updated: October 5, 2010
Health Authority: Taiwan: Department of Health

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

ClinicalTrials.gov processed this record on August 28, 2014