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
Information provided by:
Competence Network for Congenital Heart Defects Identifier:
First received: March 21, 2007
Last updated: June 5, 2012
Last verified: August 2011

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).

Condition Intervention Phase
Congenital Heart Defects
Device: implantation and testing of CRT
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Official Title: Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects

Resource links provided by NLM:

Further study details as provided by Competence Network for Congenital Heart Defects:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 55
Study Start Date: May 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00450684

AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie
Wien, Austria, A-1090
Klinikum der Universität zu Köln, Klinik und Poliklinik für Kinderkardiologie
Köln, North Rhine-Westphalia, Germany, D-50924
Universitätsklinikum Münster, Kardiologisches Zentrum für Erwachsene mit angeborenen und erworbenen Herzfehlern
Münster, North Rhine-Westphalia, Germany, D-48149
Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg
Halle, Saxony-Anhalt, Germany, D-06120
Universitätsklinikum Aachen / AÖR, Klinik für Kinderkardiologie
Aachen, Germany, D-52074
Herz- und Diabeteszentrum NRW, Klinik für Angeborene Herzfehler
Bad Oeynhausen, Germany, D-32545
Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler und Kinderkardiologie
Berlin, Germany, D-13353
Otto-Heubner-Centrum für Kinder- und Jugendmedizin, Klinik für Pädiatrie mit Schwerpunkt Kinderkardiologie CVK Charité
Berlin, Germany, D-13353
Zentrum fuer Elektrophysiologie und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie
Bremen, Germany, D-28227
Universitätsklinikum Erlangen, Kinderkardiologische Abteilung, Kinder- und Jugendklinik
Erlangen, Germany, D-91054
Klinikum der Johann-Wolfgang-Goethe-Universität Zentrum der Kinderheilkunde und Jugendmedizin, Klinik für Kinderheilkunde II mit dem Schwerpunkt Pädiatrische Kardiologie
Frankfurt am Main, Germany, D-60590
Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin, Klinik III: Angeborene Herzfehler / Pädiatrische Kardiologie
Freiburg, Germany, D-79106
Universitäres Herzzentrum Hamburg, Klinik und Poliklinik für Kinderkardiologie
Hamburg, Germany, D-20246
Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
Homburg/Saar, Germany, D-66421
Herzzentrum Leipzig, Klinik für Kinderkardiologie
Leipzig, Germany, D-04289
Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler
München, Germany, D-80336
LMU Klinikum Grosshadern, Abt. Kinderkardiologie und Pädiatrische Intensivmedizin
München, Germany, D-81377
Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie
Münster, Germany, D-48149
Asklepios Klinik Sankt Augustin, Deutsches Kinderherzzentrum, Abt. Kardiologie / Angeborene Herzfehler
Sankt Augustin, Germany, D-53757
Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin
Tübingen, Germany, D-72076
Sponsors and Collaborators
Competence Network for Congenital Heart Defects
Principal Investigator: Prof. Hashim Abdul-Khaliq, MD Competence Network for Congenital Heart Defects
  More Information

Additional Information:
No publications provided

Responsible Party: Competence Network for Congenital Heart Defects Identifier: NCT00450684     History of Changes
Other Study ID Numbers: CARE-CHD
Study First Received: March 21, 2007
Last Updated: June 5, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities processed this record on September 18, 2014