NCT00269659

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 24, 2009

Status Verified

February 1, 2009

Enrollment Period

3.5 years

First QC Date

December 22, 2005

Last Update Submit

February 23, 2009

Conditions

Mechanical DyssynchronyHeart FailureBundle-Branch Block

Keywords

Left Bundle Branch BlockRegional cardiac functionGlobal cardiac functionMechanical asynchronyEchocardiography2D echocardiographyTissue Doppler ImagingReal-time 3D echocardiographyCardiovascular Magnetic Resonance Imaging-tagging

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VU Medical Center

Amsterdam, 1081 HV, Netherlands

Location

MeSH Terms

Conditions

Heart FailureBundle-Branch Block

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesHeart BlockArrhythmias, CardiacCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Otto Kamp, MD, PhD

    Amsterdam UMC, location VUmc

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2005

First Posted

December 23, 2005

Study Start

January 1, 2004

Primary Completion

July 1, 2007

Study Completion

July 1, 2007

Last Updated

February 24, 2009

Record last verified: 2009-02

Locations

NL(1)