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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Competence Network for Congenital Heart Defects
ClinicalTrials.gov Identifier:
NCT00450684
First received: March 21, 2007
Last updated: October 9, 2014
Last verified: October 2014

March 21, 2007
October 9, 2014
May 2007
February 2012   (final data collection date for primary outcome measure)
  • Ejection fraction [ Time Frame: 7 visits ] [ Designated as safety issue: No ]
  • QRS-interval [ Time Frame: 7 visits ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function [ Time Frame: 7 visits ] [ Designated as safety issue: No ]
  • 3D echocardiography:LV volumes, LVEF, Dyssynchrony index [ Time Frame: 7 visits ] [ Designated as safety issue: No ]
  • NT pro-BNP [ Time Frame: 7 visits ] [ Designated as safety issue: No ]
  • Spiroergometry: performance P (W/kg), incl. VO2,max [ Time Frame: 6 visits ] [ Designated as safety issue: No ]
  • Walking distance in 6 minutes [ Time Frame: 6 visits ] [ Designated as safety issue: No ]
  • Decrease of hospitalization [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Decrease of ventricular and atrial arrhythmias [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Prevention or postponement of heart transplantation [ Time Frame: 18 Months ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 6 visits ] [ Designated as safety issue: No ]
  • death [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • 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
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Congenital Heart Defects
  • Device: Implantation and testing of CRT
    Biventricular pacing for 12 weeks (CRT ON) followed by automatic rhythmicity or the original, conventional biventricular stimulation for 12 weeks (CRT OFF), then returning to biventricular pacing (CRT ON).
  • Device: Implantation and testing of CRT
    Automatic rhythmicity or original conventional biventricular stimulation for 12 weeks (CRT OFF) followed by biventricular pacing (CRT ON).
  • Experimental: Group A
    Implantation and testing of CRT
    Interventions:
    • Device: Implantation and testing of CRT
    • Device: Implantation and testing of CRT
  • Experimental: Group B
    IImplantation and testing of CRT
    Interventions:
    • Device: Implantation and testing of CRT
    • Device: Implantation and testing of CRT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
September 2013
February 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with congenital heart defects
  • Heart failure of the Morphologically right or left system ventricle with an absolute ejection fraction of < 40% in the failed ventricle
  • NYHA classes II-IV
  • Optimal drug therapy for heart failure according to the ESC guidelines
  • QRS interval ≥ 120 ms (demonstrated in at least two relevant ECG derivations, depending on existing bundle branch block symptoms)
  • Patients with chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above-mentioned criteria
  • Patients with morphologically right ventricle in system position and significant insufficiency of the systemic atrioventricular valve, if they also meet the criteria listed above

Exclusion Criteria:

  • PTCA, cardiomyoplasty or myocardial infarction / unstable angina pectoris or cerebral insult within the 6 weeks preceding the planned cardiac resynchronisation therapy
  • Patients with pulmonary hypertension / Eisenmenger's syndrome
  • Life expectancy < 1 year due to a non-cardiac disease
  • Anticipated poor compliance by the patient
  • Pregnancy and breastfeeding
  • Known or persistent abuse of prescription medicines, recreational drugs or alcohol
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: Hashim Abdul-Khaliq, Prof., MD Competence Network for Congenital Heart Defects
Competence Network for Congenital Heart Defects
October 2014

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