BradycardiaNCT00704093
The Effect of Right Ventricular Pacing on Myocardial Oxidative Metabolism and Efficiency
A study testing Right ventricular pacing in people with Bradycardia, run by University of Turku at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia
- What is being tested?
- Right ventricular pacing
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2008to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Age over 18 years
- Previously implanted permanent pacemaker (DDD or VVI)
- Normal left ventricular function
Who cannot join
- Pacemaker dependency
- Symptomatic coronary artery disease
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Bradycardia
- Being tested
- Right ventricular pacing
- Keywords
- pacing, perfusion, oxidative metabolism, efficiency
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right ventricular pacingDevice
Right ventricular pacing vs. sinus rhythm or atrial pacing at the same rate
What is being measured
The primary outcome is the main question the study is designed to answer.
myocardial perfusion, oxidative metabolism and efficiency
Measured: At baseline and at 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Investigators
- Juhani Knuuti, MD, prof, Study director, Turku PET Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00704093
- Sponsor's protocol ID
- 2442007§149
- Status last verified
- Jul 2008
- First submitted
- 23 Jun 2008
- Last updated
- 4 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Right Ventricular Pacing on Myocardial Oxidative Metabolism and Efficiency
- ClinicalTrials.gov ID
- NCT00704093
- Acronym / sponsor ID
- 2442007§149
- Conditions
- Bradycardia
- Keywords
- pacing, perfusion, oxidative metabolism, efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- Jan 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 24 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent
- Age over 18 years
- Previously implanted permanent pacemaker (DDD or VVI)
- Normal left ventricular function
Key exclusion criteria (3 listed)
- Pacemaker dependency
- Symptomatic coronary artery disease
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Right ventricular pacingRight ventricular pacing vs. sinus rhythm or atrial pacing at the same rate | Device | – |
Primary outcome
myocardial perfusion, oxidative metabolism and efficiency
Time frame: At baseline and at 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juhani Knuuti, MD, prof study director
Turku PET Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Right ventricular pacing in people with Bradycardia, run by University of Turku at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
myocardial perfusion, oxidative metabolism and efficiency (time frame: At baseline and at 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2008.