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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00450684
Recruitment Status : Completed
First Posted : March 22, 2007
Last Update Posted : October 10, 2014
Sponsor:
Information provided by (Responsible Party):
Competence Network for 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).


Condition or disease Intervention/treatment Phase
Congenital Heart Defects Device: Implantation and testing of CRT Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects
Study Start Date : May 2007
Primary Completion Date : February 2012
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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).



Primary Outcome Measures :
  1. Ejection fraction [ Time Frame: 7 visits ]
  2. QRS-interval [ Time Frame: 7 visits ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450684


Locations
Austria
AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie
Wien, Austria, A-1090
Germany
Universitätsklinikum Münster, Klinik für angeborene (EMAH) und erworbene Herzfehler
Münster, North Rhine-Westphalia, Germany, D-48149
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Pädiatrische Kardiologie
Halle, Saxony-Anhalt, Germany, D-06120
Uniklinik RWTH Aachen, AÖR, Klinik für Kinderkardiologie
Aachen, Germany, D-52074
Herz- und Diabeteszentrum NRW, Klinik für Kinderkardiologie und angeborene Herzfehler
Bad Oeynhausen, Germany, D-32545
Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Kardiologie
Berlin, Germany, D-13353
Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler/Kinderkardiologie
Berlin, Germany, D-13353
Elektrophysiologie Bremen und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie
Bremen, Germany, D-28227
Universitätsklinikum Erlangen, Kinderkardiologische Abteilung
Erlangen, Germany, D-91054
Universitäts-Herzzentrum Freiburg Bad Krozingen, Zentrum für Kinder- und Jugendmedizin, Angeborene Herzfehler/Pädiatrische Kardiologie
Freiburg, Germany, D-79106
Universitäres Herzzentrum Hamburg, Kinderkardiologie
Hamburg, Germany, D-20246
Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
Homburg/Saar, Germany, D-66421
Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler
München, Germany, D-80336
Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie
Münster, Germany, D-48149
Deutsches Kinderherzzentrum Sankt Augustin, 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
Investigators
Principal Investigator: Hashim Abdul-Khaliq, Prof., MD Competence Network for Congenital Heart Defects

Additional Information:
Responsible Party: Competence Network for Congenital Heart Defects
ClinicalTrials.gov Identifier: NCT00450684     History of Changes
Other Study ID Numbers: CARE-CHD
First Posted: March 22, 2007    Key Record Dates
Last Update Posted: October 10, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities