Left Ventricular Function and Remodelling During Permanent Pacing - Full Text View

Sponsored by:	Skejby Hospital
Information provided by:	Skejby Hospital
ClinicalTrials.gov Identifier:	NCT00228241

Purpose

Background - Pacemaker treatment gives asynchronous activation of the heart that often results in decreased heart function and clinical heart failure.

New pacemaker types that stimulates both left and right ventricle ( biventricular pacemakers ) is introduced to the treatment of patients with heart failure, decreased left ventricular function and ECG signs with left bundle branch block.
Hypothesis - Ventricular pacing results in remodelling of the left ventricle and decreased left ventricular function. Biventricular pacing do not do this. Ventricular pacing results in heart failure and increased wall stress with decreased 6 minutes walk test and increased BNP in blood samples. This is not seen by biventricular pacing.
Materials and methods - 3 studies. All patients are examined by echocardiography 2-dimensional, M-mode, 3-dimensional and with tissue harmonic imaging.

Study 1) Patients with AV-conduction disorder that needs pacemaker treatment are randomized to DDD-pacemaker or biventricular pacemaker. Study 2) Patients with sick sinus syndrome included in DANPACE are randomized to AAI- or DDD-pacemaker. Study 3 ) Acute study to examine the changes in patients AV-block before DDD-pacemaker implantation and after implantation.

Condition	Intervention
Sick Sinus Syndrome AV-Block	Device: AAI vs. DDD vs. BIV pacing in different patients groups

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Left Ventricular Function and Remodelling During Permanent Pacing

Further study details as provided by Skejby Hospital:

Primary Outcome Measures:

3-dimensional left ventricular ejection fraction

Secondary Outcome Measures:

TDI echo parameters
6 MHW
NT-proBNP

Estimated Enrollment:	100
Study Start Date:	September 2003
Estimated Study Completion Date:	July 2006

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Sick sinus syndrome
AV-block

Exclusion Criteria:

Atrial fibrillation
AMI
Heart valve disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00228241

Locations

Denmark
Andi Eie Albertsen
Aarhus, Denmark, 8200

Sponsors and Collaborators

Skejby Hospital

Investigators

Study Chair:

Andi Albertsen, MD

Physician, Skejby University Hospital

More Information

No publications provided

Study ID Numbers:	130472
Study First Received:	September 26, 2005
Last Updated:	October 25, 2006
ClinicalTrials.gov Identifier:	NCT00228241 History of Changes
Health Authority:	Denmark: Ethics Committee

Keywords provided by Skejby Hospital:

Sick sinus syndrome
AV-block

Study placed in the following topic categories:

Heart Diseases
Arrhythmia, Sinus
Heart Block

Atrioventricular Block
Sick Sinus Syndrome
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Disease
Pathologic Processes
Heart Diseases
Arrhythmia, Sinus
Heart Block

Syndrome
Cardiovascular Diseases
Atrioventricular Block
Sick Sinus Syndrome
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009