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

This study has been completed.

Sponsors and Collaborators: University of Turku
Leiden University Medical Center
Information provided by: University of Turku
ClinicalTrials.gov Identifier: NCT00704093
  Purpose

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.


Condition Intervention
Bradycardia
Device: Right ventricular pacing

Genetics Home Reference related topics:   Brugada syndrome    short QT syndrome   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Basic Science, Single Blind (Investigator), Single Group Assignment, Efficacy Study
Official Title:   The Effect of Right Ventricular Pacing on Myocardial Oxidative Metabolism and Efficiency

Further study details as provided by University of Turku:

Primary Outcome Measures:
  • myocardial perfusion, oxidative metabolism and efficiency [ Time Frame: At baseline and at 2 hours ] [ Designated as safety issue: No ]

Enrollment:   10
Study Start Date:   January 2008
Study Completion Date:   June 2008
Primary Completion Date:   June 2008 (Final data collection date for primary outcome measure)

Intervention Details:
    Device: Right ventricular pacing
    Right ventricular pacing vs. sinus rhythm or atrial pacing at the same rate
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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704093

Locations
Finland
Turku PET Centre    
      Turku, Finland, 20520

Sponsors and Collaborators
University of Turku
Leiden University Medical Center

Investigators
Study Director:     Juhani Knuuti, MD, prof     Turku PET Centre    
  More Information


Responsible Party:   Turku PET Centre ( Juhani Knuuti, Director )
Study ID Numbers:   2442007§149
First Received:   June 23, 2008
Last Updated:   July 3, 2008
ClinicalTrials.gov Identifier:   NCT00704093
Health Authority:   Finland: Ethics Committee

Keywords provided by University of Turku:
pacing  
perfusion  
oxidative metabolism  
efficiency  

Study placed in the following topic categories:
Heart Diseases
Bradycardia
Arrhythmias, Cardiac

Additional relevant MeSH terms:
Pathologic Processes
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2008




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