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

Primary Purpose

Congenital Heart Defects

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Implantation and testing of CRT
Implantation and testing of CRT
Sponsored by
Competence Network for Congenital Heart Defects
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defects

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie
  • Universitätsklinikum Münster, Klinik für angeborene (EMAH) und erworbene Herzfehler
  • Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Pädiatrische Kardiologie
  • Uniklinik RWTH Aachen, AÖR, Klinik für Kinderkardiologie
  • Herz- und Diabeteszentrum NRW, Klinik für Kinderkardiologie und angeborene Herzfehler
  • Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Kardiologie
  • Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler/Kinderkardiologie
  • Elektrophysiologie Bremen und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie
  • Universitätsklinikum Erlangen, Kinderkardiologische Abteilung
  • Universitäts-Herzzentrum Freiburg Bad Krozingen, Zentrum für Kinder- und Jugendmedizin, Angeborene Herzfehler/Pädiatrische Kardiologie
  • Universitäres Herzzentrum Hamburg, Kinderkardiologie
  • Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
  • Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler
  • Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie
  • Deutsches Kinderherzzentrum Sankt Augustin, Abt. Kardiologie/Angeborene Herzfehler
  • Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

Implantation and testing of CRT

IImplantation and testing of CRT

Outcomes

Primary Outcome Measures

Ejection fraction
QRS-interval

Secondary Outcome Measures

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

Full Information

First Posted
March 21, 2007
Last Updated
October 9, 2014
Sponsor
Competence Network for Congenital Heart Defects
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1. Study Identification

Unique Protocol Identification Number
NCT00450684
Brief Title
Cardiac Resynchronization Therapy in Congenital Heart Defects
Acronym
CARE-CHD
Official Title
Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2007 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Competence Network for Congenital Heart Defects

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Implantation and testing of CRT
Arm Title
Group B
Arm Type
Experimental
Arm Description
IImplantation and testing of CRT
Intervention Type
Device
Intervention Name(s)
Implantation and testing of CRT
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Implantation and testing of CRT
Intervention Description
Automatic rhythmicity or original conventional biventricular stimulation for 12 weeks (CRT OFF) followed by biventricular pacing (CRT ON).
Primary Outcome Measure Information:
Title
Ejection fraction
Time Frame
7 visits
Title
QRS-interval
Time Frame
7 visits
Secondary Outcome Measure Information:
Title
Echocardiographic standard parameters (e.g. LVIDd. FS, RVIDd)
Time Frame
7 visits
Title
Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function
Time Frame
7 visits
Title
3D echocardiography:LV volumes, LVEF, Dyssynchrony index
Time Frame
7 visits
Title
NT pro-BNP
Time Frame
7 visits
Title
Spiroergometry: performance P (W/kg), incl. VO2,max
Time Frame
6 visits
Title
Walking distance in 6 minutes
Time Frame
6 visits
Title
Decrease of hospitalization
Time Frame
18 months
Title
Decrease of ventricular and atrial arrhythmias
Time Frame
18 months
Title
Prevention or postponement of heart transplantation
Time Frame
18 Months
Title
Quality of life
Time Frame
6 visits
Title
death
Time Frame
18 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hashim Abdul-Khaliq, Prof., MD
Organizational Affiliation
Competence Network for Congenital Heart Defects
Official's Role
Principal Investigator
Facility Information:
Facility Name
AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie
City
Wien
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Universitätsklinikum Münster, Klinik für angeborene (EMAH) und erworbene Herzfehler
City
Münster
State/Province
North Rhine-Westphalia
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Pädiatrische Kardiologie
City
Halle
State/Province
Saxony-Anhalt
ZIP/Postal Code
D-06120
Country
Germany
Facility Name
Uniklinik RWTH Aachen, AÖR, Klinik für Kinderkardiologie
City
Aachen
ZIP/Postal Code
D-52074
Country
Germany
Facility Name
Herz- und Diabeteszentrum NRW, Klinik für Kinderkardiologie und angeborene Herzfehler
City
Bad Oeynhausen
ZIP/Postal Code
D-32545
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Kardiologie
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler/Kinderkardiologie
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Elektrophysiologie Bremen und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie
City
Bremen
ZIP/Postal Code
D-28227
Country
Germany
Facility Name
Universitätsklinikum Erlangen, Kinderkardiologische Abteilung
City
Erlangen
ZIP/Postal Code
D-91054
Country
Germany
Facility Name
Universitäts-Herzzentrum Freiburg Bad Krozingen, Zentrum für Kinder- und Jugendmedizin, Angeborene Herzfehler/Pädiatrische Kardiologie
City
Freiburg
ZIP/Postal Code
D-79106
Country
Germany
Facility Name
Universitäres Herzzentrum Hamburg, Kinderkardiologie
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
City
Homburg/Saar
ZIP/Postal Code
D-66421
Country
Germany
Facility Name
Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler
City
München
ZIP/Postal Code
D-80336
Country
Germany
Facility Name
Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie
City
Münster
ZIP/Postal Code
D-48149
Country
Germany
Facility Name
Deutsches Kinderherzzentrum Sankt Augustin, Abt. Kardiologie/Angeborene Herzfehler
City
Sankt Augustin
ZIP/Postal Code
D-53757
Country
Germany
Facility Name
Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin
City
Tübingen
ZIP/Postal Code
D-72076
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.kompetenznetz-ahf.de
Description
Related Info

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Cardiac Resynchronization Therapy in Congenital Heart Defects

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