Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluating Effects of a Left Bundle Branch Block

This study has been completed.
Sponsor:
Collaborator:
The Interuniversity Cardiology Institute of the Netherlands
Information provided by:
VU University Medical Center
ClinicalTrials.gov Identifier:
NCT00269659
First received: December 22, 2005
Last updated: February 23, 2009
Last verified: February 2009

December 22, 2005
February 23, 2009
January 2004
July 2007   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00269659 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluating Effects of a Left Bundle Branch Block
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.

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
  • Mechanical Dyssynchrony
  • Heart Failure
  • Bundle-Branch Block
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
July 2007
July 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 18-85 years
  • Left bundle branch block with or without heart failure
  • Narrow QRS duration with or without heart failure

Exclusion Criteria:

  • No informed consent
  • No sinus rhythm
  • Poor acoustic window
  • For cardiovascular magnetic resonance imaging part:

    • claustrophobia
    • devices
Both
18 Years to 85 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00269659
VUMC 2003/147
No
Not Provided
VU University Medical Center
The Interuniversity Cardiology Institute of the Netherlands
Study Chair: Otto Kamp, MD, PhD VU University Medical Center
VU University Medical Center
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP