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
  Purpose

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.


Condition Phase
Mechanical Dyssynchrony
Heart Failure
Bundle-Branch Block
Phase 3

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Serial Evaluation of Left Bundle Branch Block; Role of New Imaging Techniques. Three-Dimensional Echocardiography, Tissue Doppler Imaging, and Magnetic Resonance Imaging

Resource links provided by NLM:


Further study details as provided by VU University Medical Center:

Estimated Enrollment: 100
Study Start Date: January 2004
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269659

Locations
Netherlands
VU Medical Center
Amsterdam, Netherlands, 1081 HV
Sponsors and Collaborators
VU University Medical Center
The Interuniversity Cardiology Institute of the Netherlands
Investigators
Study Chair: Otto Kamp, MD, PhD VU University Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00269659     History of Changes
Other Study ID Numbers: VUMC 2003/147
Study First Received: December 22, 2005
Last Updated: February 23, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by VU University Medical Center:
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

Additional relevant MeSH terms:
Bundle-Branch Block
Heart Block
Heart Failure
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 14, 2014