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

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).

Study Overview

• Status: Completed
• Conditions: Congenital Heart Defects
• Intervention / Treatment: Device: Implantation and testing of CRT; Device: Implantation and testing of CRT

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Austria
  • Wien, Austria, A-1090
    • AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie
• Germany
  • Aachen, Germany, D-52074
    • Uniklinik RWTH Aachen, AÖR, Klinik für Kinderkardiologie
  • Bad Oeynhausen, Germany, D-32545
    • Herz- und Diabeteszentrum NRW, Klinik für Kinderkardiologie und angeborene Herzfehler
  • Berlin, Germany, D-13353
    • Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Kardiologie
  • Berlin, Germany, D-13353
    • Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler/Kinderkardiologie
  • Bremen, Germany, D-28227
    • Elektrophysiologie Bremen und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie
  • Erlangen, Germany, D-91054
    • Universitätsklinikum Erlangen, Kinderkardiologische Abteilung
  • Freiburg, Germany, D-79106
    • Universitäts-Herzzentrum Freiburg Bad Krozingen, Zentrum für Kinder- und Jugendmedizin, Angeborene Herzfehler/Pädiatrische Kardiologie
  • Hamburg, Germany, D-20246
    • Universitäres Herzzentrum Hamburg, Kinderkardiologie
  • Homburg/Saar, Germany, D-66421
    • Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
  • München, Germany, D-80336
    • Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler
  • Münster, Germany, D-48149
    • Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie
  • Sankt Augustin, Germany, D-53757
    • Deutsches Kinderherzzentrum Sankt Augustin, Abt. Kardiologie/Angeborene Herzfehler
  • Tübingen, Germany, D-72076
    • Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin
  • North Rhine-Westphalia
    • Münster, North Rhine-Westphalia, Germany, D-48149
      • Universitätsklinikum Münster, Klinik für angeborene (EMAH) und erworbene Herzfehler
  • Saxony-Anhalt
    • Halle, Saxony-Anhalt, Germany, D-06120
      • Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Pädiatrische Kardiologie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Implantation and testing of CRT	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 B; IImplantation and testing of CRT	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Ejection fraction	7 visits
QRS-interval	7 visits

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Competence Network for Congenital Heart Defects
• Investigators: Principal Investigator: Hashim Abdul-Khaliq, Prof., MD, Competence Network for Congenital Heart Defects

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: March 21, 2007
• First Submitted That Met QC Criteria: March 21, 2007
• First Posted (Estimate): March 22, 2007

Study Record Updates

• Last Update Posted (Estimate): October 10, 2014
• Last Update Submitted That Met QC Criteria: October 9, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital
• Other Study ID Numbers: CARE-CHD