Mechanical DyssynchronyNCT00269659
Evaluating Effects of a Left Bundle Branch Block
An observational study of Mechanical Dyssynchrony and Heart Failure, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
Trial summary
A left bundle branch block (LBBB) is related to abnormal cardiac conduction and mechanical asynchrony and is associated with hypertension and coronary artery disease. Improved evaluation of left ventricular (LV) mechanical asynchrony is needed, because of the increasing number of patients with a LBBB and heart… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Mechanical Dyssynchrony, Heart Failure, Bundle-Branch Block
- How many people
- 100 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2004to Jul 2007
- Phase
- Observational
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-85 years
- Left bundle branch block with or without heart failure
- Narrow QRS duration with or without heart failure
Who cannot join
- No informed consent
- No sinus rhythm
- Poor acoustic window
- For cardiovascular magnetic resonance imaging part:
- claustrophobia
- devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serial Evaluation of Left Bundle Branch Block; Role of New Imaging Techniques. Three-Dimensional Echocardiography, Tissue Doppler Imaging, and Magnetic Resonance Imaging
A left bundle branch block (LBBB) is related to abnormal cardiac conduction and mechanical asynchrony and is associated with hypertension and coronary artery disease. Improved evaluation of left ventricular (LV) mechanical asynchrony is needed, because of the increasing number of patients with a LBBB and heart failure. A variety of patterns of mechanical activation can be observed in LBBB patients.
Novel imaging modalities such as tissue Doppler imaging, real-time 3D echocardiography and cardiovascular magnetic resonance imaging provide information about regional and global LV function in healthy subjects, patients without a LBBB with heart failure, patients with a LBBB without heart failure, and patients with a LBBB with heart failure.
Read more
The investigators want to evaluate the different patient groups with the novel imaging modalities and they want to compare the novel imaging modalities with each other.
The investigators hypothesized that, between the groups, differences concerning regional and global LV function are measurable.
Each novel imaging technique has its own advantages and limitations but are comparable in measuring regional and global LV function.
Read the detailed description
Within a time period of 3 years we evaluate different groups of patients and measure regional and global cardiac function.
Therefore, we developed an echocardiography screening-protocol in which we use conventional 2D echocardiography and conventional Doppler echocardiography, extended with tissue Doppler imaging and real-time 3D echo acquisitions.
In a limited group of patients we perform a specially designed cardiovascular magnetic resonance imaging protocol which uses artificially induced grid-lines to evaluate regional and global cardiac function.
Patients are referred to our hospital because of evaluation of their LBBB and or heart failure. We ask them if they would like to undergo the echocardiography and the cardiovascular magnetic resonance imaging.
After a year we want to repeat the measurements in a small group of the patients to re-evaluate regional and global cardiac function.
All patients should have a sinus rhythm and adequate acoustic windows. Patients should not have contraindications for cardiovascular magnetic resonance imaging.
- Conditions
- Mechanical Dyssynchrony, Heart Failure, Bundle-Branch Block
- Keywords
- Left Bundle Branch Block, Regional cardiac function, Global cardiac function, Mechanical asynchrony, Echocardiography, 2D echocardiography, Tissue Doppler Imaging, Real-time 3D echocardiography, Cardiovascular Magnetic Resonance Imaging-tagging
- Medical subject headings
- Heart Failure, Bundle-Branch Block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2005 (estimated)
- Study startJan 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical DyssynchronyStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Collaborators
- The Interuniversity Cardiology Institute of the Netherlands
- Investigators
- Otto Kamp, MD, PhD, Study chair, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00269659
- Sponsor's protocol ID
- VUMC 2003/147
- Status last verified
- Feb 2009
- First submitted
- 22 Dec 2005
- Last updated
- 24 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Evaluation of Left Bundle Branch Block; Role of New Imaging Techniques. Three-Dimensional Echocardiography, Tissue Doppler Imaging, and Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00269659
- Acronym / sponsor ID
- VUMC 2003/147
- Conditions
- Mechanical Dyssynchrony, Heart Failure, Bundle-Branch Block
- Keywords
- Left Bundle Branch Block, Regional cardiac function, Global cardiac function, Mechanical asynchrony, Echocardiography, 2D echocardiography, Tissue Doppler Imaging, Real-time 3D echocardiography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Collaborators
- The Interuniversity Cardiology Institute of the Netherlands
- Study start
- Jan 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 23 Dec 2005 (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.
A left bundle branch block (LBBB) is related to abnormal cardiac conduction and mechanical asynchrony and is associated with hypertension and coronary artery disease. Improved evaluation of left ventricular (LV) mechanical asynchrony is needed, because of the increasing number of patients with a LBBB and heart failure. A variety of patterns of mechanical activation can be observed in LBBB patients.
Novel imaging modalities such as tissue Doppler imaging, real-time 3D echocardiography and cardiovascular magnetic resonance imaging provide information about regional and global LV function in healthy subjects, patients without a LBBB with heart failure, patients with a LBBB without heart failure, and patients with a LBBB with heart failure.
The investigators want to evaluate the different patient groups with the novel imaging modalities and they want to compare the novel imaging modalities with each other.
The investigators hypothesized that, between the groups, differences concerning regional and global LV function are measurable.
Each novel imaging technique has its own advantages and limitations but are comparable in measuring regional and global LV function.
Detailed description
Within a time period of 3 years we evaluate different groups of patients and measure regional and global cardiac function.
Therefore, we developed an echocardiography screening-protocol in which we use conventional 2D echocardiography and conventional Doppler echocardiography, extended with tissue Doppler imaging and real-time 3D echo acquisitions.
In a limited group of patients we perform a specially designed cardiovascular magnetic resonance imaging protocol which uses artificially induced grid-lines to evaluate regional and global cardiac function.
Patients are referred to our hospital because of evaluation of their LBBB and or heart failure. We ask them if they would like to undergo the echocardiography and the cardiovascular magnetic resonance imaging.
After a year we want to repeat the measurements in a small group of the patients to re-evaluate regional and global cardiac function.
All patients should have a sinus rhythm and adequate acoustic windows. Patients should not have contraindications for cardiovascular magnetic resonance imaging.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-85 years
- Left bundle branch block with or without heart failure
- Narrow QRS duration with or without heart failure
Key exclusion criteria (6 listed)
- No informed consent
- No sinus rhythm
- Poor acoustic window
- For cardiovascular magnetic resonance imaging part:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 24 Feb 2009.
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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.
Otto Kamp, MD, PhD study chair
Amsterdam UMC, location VUmc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Dyssynchrony and Heart Failure, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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 3 inclusion and 6 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 24 Feb 2009. 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 Netherlands. 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.
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 24 Feb 2009.