Cardiac Resynchronization Therapy in Congenital Heart Defects

Congenital Heart Defects Clinical Trial

— CARE-CHD  

Official title:

Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00450684
• Other study ID #: CARE-CHD
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 21, 2007
• Last updated: October 9, 2014
• Start date: May 2007
• Est. completion date: September 2013

Study information

• Verified date: October 2014
• Source: Competence Network for Congenital Heart Defects
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 2013
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital

Intervention

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).
• Implantation and testing of CRT
Automatic rhythmicity or original conventional biventricular stimulation for 12 weeks (CRT OFF) followed by biventricular pacing (CRT ON).

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Competence Network for Congenital Heart Defects

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ejection fraction		7 visits	No
Primary	QRS-interval		7 visits	No
Secondary	Echocardiographic standard parameters (e.g. LVIDd. FS, RVIDd)		7 visits	No
Secondary	Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function		7 visits	No
Secondary	3D echocardiography:LV volumes, LVEF, Dyssynchrony index		7 visits	No
Secondary	NT pro-BNP		7 visits	No
Secondary	Spiroergometry: performance P (W/kg), incl. VO2,max		6 visits	No
Secondary	Walking distance in 6 minutes		6 visits	No
Secondary	Decrease of hospitalization		18 months	No
Secondary	Decrease of ventricular and atrial arrhythmias		18 months	No
Secondary	Prevention or postponement of heart transplantation		18 Months	No
Secondary	Quality of life		6 visits	No
Secondary	death		18 months	No

External Links

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