Cardiac Resynchronization Therapy in Congenital Heart Defects - Full Text View

Sponsored by:	Competence Network for Congenital Heart Defects
Information provided by:	Competence Network for Congenital Heart Defects
ClinicalTrials.gov Identifier:	NCT00450684

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. Immediately after Implantation the patients are divided into group A and B (blind randomized, cross-over design).

Patients who reject the randomization or cannot be paced with right ventricular pacing alone will be enrolled in group C with continuous biventricular pacing.

The treatment and the completing follow-up examination will take approximately 18 months and includes eight visits - one previous to the CRT and seven at certain times afterwards. At selected time intervals echocardiographic §D and Tissue Doppler imaging to evaluate the global and regional ventricular function are performed. Subjective (questionnaire) and objective assessment of the physical performance (VO2 max) will also be performed at the defined follow-up intervals. Within two years, 80 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, exercise capacity and quality of life.

Condition	Intervention	Phase
Congenital Heart Defects	Device: implantation and testing of CRT	Phase II Phase III

MedlinePlus related topics: Congenital Heart Defects

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects

Further study details as provided by Competence Network for Congenital Heart Defects:

Primary Outcome Measures:

Ejection fraction [ Time Frame: 7 visits ]
VO2max [ Time Frame: 7 visits ]
QRS-interval [ Time Frame: 7 visits ]

Secondary Outcome Measures:

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

Estimated Enrollment:	80
Study Start Date:	May 2007
Estimated Study Completion Date:	July 2009

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

congenital heart defect
morphologic heart failure of the right or left system ventricle with an ejection fraction of absolute <= 40%
NYHA II - IV
optimal drug therapy for heart failure according to the ESC guidelines
QRS-interval >= 120 ms (according to at least two ECG)
chronic stimulation of the subpulmonary ventricle by a 1- or 2-ventricle pacemaker, which also meets the above mentioned criteria
morphologically right ventricle in system position and significant insufficiency of the systemic AV valve, which also meets the above mentioned criteria
electromechanic dyssynchrony as defined in study protocol

Exclusion Criteria:

PTCA, cardiomyoplasty, myocardium infarction, instable angina pectoris or cerebral insult within 6 weeks before the planned cardiac resynchronization therapy
pulmonary hypertension/Eisenmenger syndrome
univentricular heart without Fontan procedure
life expectancy less than 1 year due to a non-cardiac disease
expected poor compliance of the patient, e.g. Trisomic 21 or other mental retardation
ergospirometry cannot be performed
pregnancy
participation in a clinical trial within the last 4 weeks or current participation in a clinical trial (except studies of the Competence Network for Congenital Heart Defects)
diseases or functional disorders that exclude participation according to physician's convenience
poor cooperation
known or continuous drug or alcohol abuse

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00450684

Contacts

Contact: Prof. Hashim Abdul-Khaliq, MD	+49-6841-16 28305	abdul-khaliq@uniklinikum-saarland.de
Contact: Axel Rentzsch, MD	+49-6841-16 28320	axel.rentzsch@uniklinikum-saarland.de

Locations

Austria
AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie	Recruiting
Wien, Austria, A-1090
Contact: Prof. Ulrike Salzer-Muhar, MD +43-4-40400 3217 ulrike.salzer@meduniwien.ac.at
Contact: Christiane Pees, MD +43-4-40400 3290 christiane.pees@meduniwien.ac.at
Principal Investigator: Prof. Ulrike Salzer-Muhar, MD
Sub-Investigator: Christiane Pees, MD
Germany
Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie	Recruiting
Homburg/Saar, Germany, D-66421
Contact: Prof. Hashim Abdul-Khaliq, MD +49-6841-16 28306 abdul-khaliq@uniklinikum-saarland.de
Principal Investigator: Prof. Hashim Abdul-Khaliq, MD
Sub-Investigator: Axel Rentzsch, MD
Sub-Investigator: Tanja Rädle-Hurst, MD
Herzzentrum Leipzig, Klinik für Kinderkardiologie	Recruiting
Leipzig, Germany, D-04289
Contact: Prof. Jan Janousek, MD +49-341-865 1037 jan.janousek@medizin.uni-leipzig.de
Principal Investigator: Prof. Jan Janousek, MU Dr
Sub-Investigator: Ingo Dähnert, MD
Zentrum fuer Elektrophysiologie und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie	Recruiting
Bremen, Germany, D-28227
Contact: Joachim Hebe, MD +49 421 87 91 789 j.hebe@online.de
Contact: Jan-Hendrik Nürnberg, MD jan-hendrik.nuernberg@klinikum-bremen-ldw.de
Principal Investigator: Jooachim Hebe, MD
Sub-Investigator: Jan-Hendrik Nürnberg, MD
Sub-Investigator: Christoph Heuser, MD
Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler	Recruiting
München, Germany, D-80336
Contact: Prof. John Hess, MD +49-89-1218 3010 hess@dhm.mhn.de
Principal Investigator: Andreas Pflaumer, MD
Sub-Investigator: Prof. John Hess, MD
Sub-Investigator: Christof Kolb, MD
Herz- und Diabeteszentrum NRW, Klinik für Angeborene Herzfehler	Recruiting
Bad Oeynhausen, Germany, D-32545
Contact: Prof. Deniz Kececioglu, MD +49-5731-97 1381 dkececioglu@hdz-nrw.de
Principal Investigator: Prof. Deniz Kececioglu, MD
Sub-Investigator: Thorsten Laser, MD
Sub-Investigator: Rainer Schäffler, MD
Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler und Kinderkardiologie	Recruiting
Berlin, Germany, D-13353
Contact: Prof. Felix Berger, MD +49-30-4593 2800 berger@dhzb.de
Contact: Björn Peters, MD +49-30-4593 2800 peters@dhzb.de
Principal Investigator: Björn Peters, MD
Sub-Investigator: Mustafa Yegitbasi, MD
Sub-Investigator: Oliver Miera, MD
Sub-Investigator: Mojtaba Abedini, MD
Sub-Investigator: Yousof Ghanem, MD
Sub-Investigator: Boris Jäckel, MD
Sub-Investigator: Sarah Eder
Sub-Investigator: Dirk Schneider-Kulla, MD
Otto-Heubner-Centrum für Kinder- und Jugendmedizin, Klinik für Pädiatrie mit Schwerpunkt Kinderkardiologie CVK Charité	Recruiting
Berlin, Germany, D-13353
Contact: Joachim C. Will, MD +49-30-450 616109 achim.will@charite.de
Contact: Prof. Felix Berger, MD +49-30-450 516041 felix.berger@charite.de
Principal Investigator: Joachim C. Will, MD
Sub-Investigator: Bernd Opgen-Rhein, MD
Sub-Investigator: Birgit Franzbach, MD
Universitätsklinikum Aachen / AÖR, Klinik für Kinderkardiologie	Recruiting
Aachen, Germany, D-52074
Contact: Prof. Hedwig Hövels-Gürich, MD +49-241-8036-253 hhoevels-guerich@ukaachen.de
Contact: Simone Köster, MD +49-241-8035-578 skoester@ukaachen.de
Principal Investigator: Prof. Hedwig Hövels-Gürich, MD
Sub-Investigator: Simone Köster, MD
LMU Klinikum Grosshadern, Abt. Kinderkardiologie und Pädiatrische Intensivmedizin	Recruiting
München, Germany, D-81377
Contact: Prof. Heinrich Netz, MD +49-089-7095 3941 heinrich.netz@med.uni-muenchen.de
Contact: Robert Dalla Pozza, MD +49-89-7095 3041 robert.dallapozza@med.uni-muenchen.de
Principal Investigator: Prof. Heinrich Netz, MD
Sub-Investigator: Robert Dalla Pozza, MD
Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie	Recruiting
Münster, Germany, D-48149
Contact: Hans Gerd Kehl, MD +49-251-834 7796 kehl@ukmuenster.de
Contact: Sybille Singer, MD +49-251-834 7773 sybille.singer@uni-muenster.de
Principal Investigator: Hans Gerd Kehl, MD
Sub-Investigator: Sybille Singer, MD
Asklepios Klinik Sankt Augustin, Deutsches Kinderherzzentrum, Abt. Kardiologie / Angeborene Herzfehler	Recruiting
Sankt Augustin, Germany, D-53757
Contact: Peter Zartner, MD +49-2241 249 650 p.zartner@asklepios.com
Contact: Rolf Kallenberg, MD r.kallenberg@asklepios.com
Principal Investigator: Peter Zartner, MD
Sub-Investigator: Rolf Kallenberg, MD
Sub-Investigator: Ronald Handke, MD
Sub-Investigator: Nicole Toussaint-Götz, MD
Sub-Investigator: Michael Kaestner, MD
Klinikum der Johann-Wolfgang-Goethe-Universität Zentrum der Kinderheilkunde und Jugendmedizin, Klinik für Kinderheilkunde II mit dem Schwerpunkt Pädiatrische Kardiologie	Recruiting
Frankfurt am Main, Germany, D-60590
Contact: Tobias Schuster, MD +49-69-6301 5759 tobias.schuster@kgu.de
Contact: Anoosh Esmaeili, MD anoosh.esmaeili@kgu.de
Principal Investigator: Tobias Schuster, MD
Sub-Investigator: Anoosh Esmaeili, MD
Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin	Recruiting
Tübingen, Germany, D-72076
Contact: Matthias Gass, MD +49-7071-298 3781 matthias.gass@med.uni-tuebingen.de
Contact: Christian Apitz, MD +49-7071-298 1443 christian.apitz@med.uni-tuebingen.de
Principal Investigator: Matthias Gass, MD
Sub-Investigator: Christian Apitz, MD
Universitätsklinikum Erlangen, Kinderkardiologische Abteilung, Kinder- und Jugendklinik	Recruiting
Erlangen, Germany, D-91054
Contact: Prof. Sven Dittrich, MD +49-9131-853 3750 sven.dittrich@kinder.imed.uni-erlangen.de
Contact: Theresa Seeliger, MD +49-9131-853 5301 theresa.seeliger@med2.imed.uni-erlangen.de
Principal Investigator: Prof. Sven Dittrich, MD
Sub-Investigator: Theresa Seeliger, MD
Sub-Investigator: Stefan Zink, MD
Universitäres Herzzentrum Hamburg, Klinik und Poliklinik für Kinderkardiologie	Recruiting
Hamburg, Germany, D-20246
Contact: Thomas S. Mir, MD +49-40-42803 3718 mir@uke.uni-hamburg.de
Contact: Christian Thiel, MD +49-40-42803 3718
Principal Investigator: Thomas S. Mir, MD
Sub-Investigator: Christian Thiel, MD
Sub-Investigator: Gesa Harring, MD
Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin, Klinik III: Angeborene Herzfehler / Pädiatrische Kardiologie	Recruiting
Freiburg, Germany, D-79106
Contact: Jochen Grohmann, MD +49-761-270 4317 jochen.grohmann@uniklinik-freiburg.de
Contact: Raoul Arnold, MD +49-0761-270 4318 raoul.arnold@uniklinik-freiburg.de
Principal Investigator: Jochen Grohmann, MD
Sub-Investigator: Raoul Arnold, MD

Sponsors and Collaborators

Competence Network for Congenital Heart Defects

Investigators

Principal Investigator:

Prof. Hashim Abdul-Khaliq, MD

Competence Network for Congenital Heart Defects

Study ID Numbers:	CARE-CHD
Study First Received:	March 21, 2007
Last Updated:	March 26, 2009
ClinicalTrials.gov Identifier:	NCT00450684 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices