Clinical trial NCT00450684: Cardiac Resynchronization Therapy in Congenital Heart Defects
Official title: Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Congenital Heart Defects
Lead sponsor: Competence Network for Congenital Heart Defects
Sponsor class: OTHER_GOV
First posted: 2007-03-22
Enrollment: 55
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Ejection fraction
timeFrame: 7 visits
measure: QRS-interval
timeFrame: 7 visits
Secondary outcomes:
measure: Echocardiographic standard parameters (e.g. LVIDd. FS, RVIDd)
timeFrame: 7 visits
measure: Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function
timeFrame: 7 visits
measure: 3D echocardiography:LV volumes, LVEF, Dyssynchrony index
timeFrame: 7 visits
measure: NT pro-BNP
timeFrame: 7 visits
measure: Spiroergometry: performance P (W/kg), incl. VO2,max
timeFrame: 6 visits
measure: Walking distance in 6 minutes
timeFrame: 6 visits
measure: Decrease of hospitalization
timeFrame: 18 months
measure: Decrease of ventricular and atrial arrhythmias
timeFrame: 18 months
measure: Prevention or postponement of heart transplantation
timeFrame: 18 Months
measure: Quality of life
timeFrame: 6 visits
measure: death
timeFrame: 18 months
Other outcomes:
Locations:
city: Wien
country: Austria
facility: AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik für angeborene (EMAH) und erworbene Herzfehler
state: North Rhine-Westphalia
city: Halle
country: Germany
facility: Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Pädiatrische Kardiologie
state: Saxony-Anhalt
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen, AÖR, Klinik für Kinderkardiologie
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW, Klinik für Kinderkardiologie und angeborene Herzfehler
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Kardiologie
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler/Kinderkardiologie
city: Bremen
country: Germany
facility: Elektrophysiologie Bremen und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen, Kinderkardiologische Abteilung
city: Freiburg
country: Germany
facility: Universitäts-Herzzentrum Freiburg Bad Krozingen, Zentrum für Kinder- und Jugendmedizin, Angeborene Herzfehler/Pädiatrische Kardiologie
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg, Kinderkardiologie
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie
city: München
country: Germany
facility: Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie
city: Sankt Augustin
country: Germany
facility: Deutsches Kinderherzzentrum Sankt Augustin, Abt. Kardiologie/Angeborene Herzfehler
city: Tübingen
country: Germany
facility: Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin
Study officials:
affiliation: Competence Network for Congenital Heart Defects
name: Hashim Abdul-Khaliq, Prof., MD
role: PRINCIPAL_INVESTIGATOR
References: