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The Effect of Right Ventricular Pacing on Myocardial Oxidative Metabolism and Efficiency

Primary Purpose

Bradycardia

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Right ventricular pacing
Sponsored by
University of Turku
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Bradycardia focused on measuring pacing, perfusion, oxidative metabolism, efficiency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent
  • Age over 18 years
  • Previously implanted permanent pacemaker (DDD or VVI)
  • Normal left ventricular function

Exclusion Criteria:

  • Pacemaker dependency
  • Symptomatic coronary artery disease
  • Pregnancy

Sites / Locations

  • Turku PET Centre

Outcomes

Primary Outcome Measures

myocardial perfusion, oxidative metabolism and efficiency

Secondary Outcome Measures

Full Information

First Posted
June 23, 2008
Last Updated
July 3, 2008
Sponsor
University of Turku
Collaborators
Leiden University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00704093
Brief Title
The Effect of Right Ventricular Pacing on Myocardial Oxidative Metabolism and Efficiency
Official Title
The Effect of Right Ventricular Pacing on Myocardial Oxidative Metabolism and Efficiency
Study Type
Interventional

2. Study Status

Record Verification Date
July 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Turku
Collaborators
Leiden University Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Right ventricular (RV) apical pacing induces a left bundle branch block (LBBB) type electrical activation sequence in the heart. This abnormal activation pattern of the ventricles may have detrimental effects on cardiac structure and function. RV pacing has been shown to impair left ventricular (LV) function both in normal and failing hearts. Importantly, it has been demonstrated that this deterioration in LV function is related to the presence of LV dyssynchrony during RV pacing. The exact effects of RV pacing on myocardial perfusion, oxidative metabolism and cardiac efficiency have not been fully elucidated. The objective of the present study is to evaluate the effect of RV pacing on both global and regional oxidative metabolism and perfusion, and myocardial efficiency. In addition, the effect of RV pacing induced LV dyssynchrony on myocardial oxidative metabolism and efficiency will be studied. Our hypothesis is that LV dyssynchrony during RV pacing results in regional abnormalities in LV perfusion and oxidative metabolism. LV dyssynchrony will also result in altered myocardial efficiency.
Detailed Description
Right ventricular (RV) apical pacing induces a left bundle branch block (LBBB) type electrical activation sequence in the heart. This abnormal activation pattern of the ventricles may have detrimental effects on cardiac structure and function. Several clinical trials have demonstrated an association between RV pacing and an increased risk of heart failure and death. In addition, RV pacing has been shown to impair left ventricular (LV) function both in normal and failing hearts. Importantly, it has been demonstrated that this deterioration in LV function is related to the presence of LV dyssynchrony during RV pacing. The exact effects of RV pacing on myocardial perfusion, oxidative metabolism and cardiac efficiency have not been fully elucidated. Importantly, the relation between the presence of LV dyssynchrony during RV pacing and changes in myocardial perfusion, oxidative metabolism and cardiac efficiency has not been studied. Ten patients with normal LV ejection fraction and VVI/DDD pacemaker will be studied during AAI-pacing/sinus rhythm without RV pacing (pacing-OFF) and with RV-pacing (pacing-ON) at the same heart rate. Dynamic [15O]water and [11C]acetate positron emission tomography is used to measure perfusion and oxidative metabolism (kmono) of the LV. An echocardiographic examination is used to assess LV stroke volume (SV) and LV dyssynchrony. The PET data will be first analyzed based on RV pacing mode only, comparing the two pacing conditions (pacing-ON vs. pacing-OFF). Thereafter, the study population will be divided into two groups, according to the presence of LV dyssynchrony during RV pacing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bradycardia
Keywords
pacing, perfusion, oxidative metabolism, efficiency

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Right ventricular pacing
Intervention Description
Right ventricular pacing vs. sinus rhythm or atrial pacing at the same rate
Primary Outcome Measure Information:
Title
myocardial perfusion, oxidative metabolism and efficiency
Time Frame
At baseline and at 2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent Age over 18 years Previously implanted permanent pacemaker (DDD or VVI) Normal left ventricular function Exclusion Criteria: Pacemaker dependency Symptomatic coronary artery disease Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juhani Knuuti, MD, prof
Organizational Affiliation
Turku PET Centre
Official's Role
Study Director
Facility Information:
Facility Name
Turku PET Centre
City
Turku
ZIP/Postal Code
20520
Country
Finland

12. IPD Sharing Statement

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