Cardiac Resynchronization Therapy in Congenital Heart Defects (CARE-CHD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Competence Network for Congenital Heart Defects.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Competence Network for Congenital Heart Defects
ClinicalTrials.gov Identifier:
NCT00450684
First received: March 21, 2007
Last updated: June 5, 2012
Last verified: August 2011

March 21, 2007
June 5, 2012
May 2007
September 2013   (final data collection date for primary outcome measure)
  • Ejection fraction [ Time Frame: 7 visits ]
  • QRS-interval [ Time Frame: 7 visits ]
  • Ejection fraction
  • QRS-interval
  • VO2max
Complete list of historical versions of study NCT00450684 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Not Provided
Not Provided
 
Cardiac Resynchronization Therapy in Congenital Heart Defects
Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects

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).

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Congenital Heart Defects
Device: implantation and testing of CRT
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
55
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • congenital heart defect
  • morphologic heart failure of the right or left system ventricle with an ejection fraction of absolute <= 40%
  • NYHA II - IV
  • optimal drug therapy for heart failure according to the ESC guidelines
  • QRS-interval >= 120 ms (according to at least two ECG)
  • chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above mentioned criteria
  • morphologically right ventricle in system position and significant insufficiency of the systemic AV valve, which also meets the above mentioned criteria
  • electromechanic dyssynchrony as defined in study protocol

Exclusion Criteria:

  • PTCA, cardiomyoplasty, myocardium infarction, instable angina pectoris or cerebral insult within 6 weeks before the planned cardiac resynchronization therapy
  • pulmonary hypertension/Eisenmenger syndrome
  • univentricular heart without Fontan procedure
  • life expectancy less than 1 year due to a non-cardiac disease
  • expected poor compliance of the patient, e.g. Trisomic 21 or other mental retardation
  • ergospirometry cannot be performed
  • pregnancy
  • participation in a clinical trial within the last 4 weeks or current participation in a clinical trial (except studies of the Competence Network for Congenital Heart Defects)
  • diseases or functional disorders that exclude participation according to physician's convenience
  • poor cooperation
  • known or continuous drug or alcohol abuse
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Germany
 
NCT00450684
CARE-CHD
Not Provided
Competence Network for Congenital Heart Defects
Competence Network for Congenital Heart Defects
Not Provided
Principal Investigator: Prof. Hashim Abdul-Khaliq, MD Competence Network for Congenital Heart Defects
Competence Network for Congenital Heart Defects
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP