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
  Purpose

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: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 ] [ Designated as safety issue: No ]
  • QRS-interval [ Time Frame: 7 visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 55
Study Start Date: May 2007
Study Completion Date: September 2013
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler/Kinderkardiologie
Berlin, Germany, D-13353
Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Kardiologie
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
  More Information

Additional Information:
No publications provided

Responsible Party: Competence Network for Congenital Heart Defects
ClinicalTrials.gov Identifier: NCT00450684     History of Changes
Other Study ID Numbers: CARE-CHD
Study First Received: March 21, 2007
Last Updated: October 9, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on October 23, 2014