Evaluating Effects of a Left Bundle Branch Block

Heart Failure Clinical Trial

Official title:

Serial Evaluation of Left Bundle Branch Block; Role of New Imaging Techniques. Three-Dimensional Echocardiography, Tissue Doppler Imaging, and Magnetic Resonance Imaging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269659
• Other study ID #: VUMC 2003/147
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2005
• Last updated: February 23, 2009
• Start date: January 2004
• Est. completion date: July 2007

Study information

• Verified date: February 2009
• Source: VU University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Bundle-Branch Block
• Heart Block
• Heart Failure
• Mechanical Dyssynchrony

Locations

Country	Name	City	State
Netherlands	VU Medical Center	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
VU University Medical Center	The Interuniversity Cardiology Institute of the Netherlands

Country where clinical trial is conducted

Netherlands,