Clinical Trial: Left Ventricular Function and Remodelling During Permanent Pacing

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Left Ventricular Function and Remodelling During Permanent Pacing

Brief Summary:

  1. 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.
  2. 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.
  3. 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.

Detailed Summary:
Sponsor: Aarhus University Hospital Skejby

Current Primary Outcome: 3-dimensional left ventricular ejection fraction

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • TDI echo parameters
  • 6 MHW
  • NT-proBNP


Original Secondary Outcome: Same as current

Information By: Aarhus University Hospital Skejby

Dates:
Date Received: September 26, 2005
Date Started: September 2003
Date Completion: July 2006
Last Updated: October 25, 2006
Last Verified: September 2005