Clinical Trial: Cardiac Resynchronization Therapy in Congenital Heart Defects

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects

Brief Summary:

The objective of this multicentre prospective therapeutic study is to evaluate the effects of CRT on the right and left ventricular function of patients with CHD in the medium and long term. Patients who reject the randomization or cannot be paced with right ventricular pacing alone will be enrolled in group C with continuous biventricular pacing, which is the main group in this study. Optional: Immediately after implantation the patients are divided into group A and B (randomized, single blind (for the patient), cross-over design).

The treatment and the completing follow-up examination will take approximately 18 months and includes seven visits - one previous to the CRT and six at certain times afterward. At selected time intervals echocardiographic 3D and Tissue Doppler Imaging to evaluate the global and regional ventricular function are performed. Subjective quality of life assessment (questionnaire) will also be performed at the defined follow-up intervals, and if applicable (optional) also objective assessment of the physical performance (VO2 max).

55 patients also including children and adults with CHD are planned to be included in the study. The main target is to provide evidence of the effectiveness of CRT with biventricular stimulation in terms of improved ventricular function (ejection fraction and QRS interval).


Detailed Summary:
Sponsor: Competence Network for Congenital Heart Defects

Current Primary Outcome:

  • Ejection fraction [ Time Frame: 7 visits ]
  • QRS-interval [ Time Frame: 7 visits ]


Original Primary Outcome:

  • Ejection fraction
  • VO2max
  • QRS-interval


Current Secondary Outcome:

  • Echocardiographic standard parameters (e.g. LVIDd. FS, RVIDd) [ Time Frame: 7 visits ]
  • Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function [ Time Frame: 7 visits ]
  • 3D echocardiography:LV volumes, LVEF, Dyssynchrony index [ Time Frame: 7 visits ]
  • NT pro-BNP [ Time Frame: 7 visits ]
  • Spiroergometry: performance P (W/kg), incl. VO2,max [ Time Frame: 6 visits ]
  • Walking distance in 6 minutes [ Time Frame: 6 visits ]
  • Decrease of hospitalization [ Time Frame: 18 months ]
  • Decrease of ventricular and atrial arrhythmias [ Time Frame: 18 months ]
  • Prevention or postponement of heart transplantation [ Time Frame: 18 Months ]
  • Quality of life [ Time Frame: 6 visits ]
  • death [ Time Frame: 18 months ]


Original Secondary Outcome:

  • Echocardiographic standard parameters (e.g. LVIDd. FS, RVIDd)
  • Tissue Doppler echocardiography: dyssynchronic parameters, regional myocardic function
  • 3D echocardiography:LV volumes, LVEF, Dyssynchronic index
  • Pro-BNP
  • Spiroergometry: performance P (W/kg)
  • Walking distance in 6 minutes
  • Decrease of hospitalization
  • Decrease of ventricular and atrial arrhythmias
  • Prevention or postponement of heart transplantation
  • Quality of life


Information By: Competence Network for Congenital Heart Defects

Dates:
Date Received: March 21, 2007
Date Started: May 2007
Date Completion:
Last Updated: October 9, 2014
Last Verified: October 2014