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

Ages Eligible for Study:	8 Years and older
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: Hashim Abdul-Khaliq, Prof. Dr. med.	+49 6841 16 28305	abdul-khaliq@uniklinikum-saarland.de
Contact: Axel Rentzsch, Dr. med.	+49 6841 1628320	axel.rentzsch@uniklinikum-saarland.de

Locations

Austria
AKH Wien, Kinderheilkunde/Kinderkardiologie	Recruiting
Wien, Austria, A-1090
Contact: Ulrike Salzer-Muhar, Prof. Dr. med. +43-4-40400-3217 ulrike.salzer@meduniwien.ac.at
Contact: Christiane Pees, Dr. med +43-4-40400-3290 christiane.pees@meduniwien.ac.at
Principal Investigator: Ulrike Salzer-Muhar, Prof. Dr. med.
Sub-Investigator: Christiane Pees, Dr. med.
Sub-Investigator: Thomas Binder, Prof. Dr. med.
Germany
Universitätsklinikum des Saarlandes	Recruiting
Homburg/Saar, Germany, 66421
Contact: Hashim Abdul-Khaliq, Prof. Dr. med. +49 6841 1628306 abdul-khaliq@uniklinikum-saarland.de
Principal Investigator: Hashim Abdul-Khaliq, Prof. Dr. med.
Sub-Investigator: Axel Rentzsch, Dr. med.
Sub-Investigator: Tanja Raedle-Hurst, Dr. med.
Herzzentrum Leipzig	Recruiting
Leipzig, Germany, 04289
Contact: Jan Janousek, Prof. Dr. med. +49 341 865 1037 jan.janousek@medizin.uni-leipzig.de
Sub-Investigator: Ingo Daehnert, Dr. med.
Principal Investigator: Jan Janousek, Prof. MUDr.
Zentrum fuer Elektrophysiologie und Herzzentrum Bremen	Recruiting
Bremen, Germany, 28227
Contact: Joachim Hebe, Dr. med. +49 421 87 91 789 j.hebe@online.de
Contact: Jan-Hendrik Nuernberg, Dr. med jan-hendrik.nuernberg@klinikum-bremen-ldw.de
Principal Investigator: Jooachim Hebe, Dr. med.
Sub-Investigator: Jan-Hendrik Nuernberg, Dr. med.
Sub-Investigator: Goetz Buchwolski, Dr. med.
Deutsches Herzzentrum Muenchen	Recruiting
Munich, Germany, 80336
Contact: John Hess, Prof. Dr. med. +49 89 12 18 0 hess@dhm.mhn.de
Principal Investigator: Andreas Pflaumer, Dr. med.
Sub-Investigator: John Hess, Prof. Dr. med.
Sub-Investigator: Christof Kolb, Dr.
Herz- und Diabeteszentrum NRW	Recruiting
Bad Oeynhausen, Germany, 32545
Contact: Deniz Kececioglu, Prof. Dr. med. +49 5731 97 13 81 dkececioglu@hdz-nrw.de
Sub-Investigator: Thorsten Laser, Dr. med.
Sub-Investigator: Rainer Schaeffler, Dr. med.
Principal Investigator: Deniz Kececioglu, Prof. Dr. med.
Klinik und Poliklinik fuer Kinderkardiologie	Not yet recruiting
Cologne, Germany, 50922
Contact: K. Brockmeier, Prof. Dr. med. +49221 478 86301 kinderkardiologie@medizin.uni-koeln.de
Contact: Matthias Alexander Emmel, Dr. med. matthias.emmel@uk-koeln.de
Principal Investigator: Matthias Alexander Emmel, PD Dr. med.
Sub-Investigator: Frank Pillekamp, Dr. med.
Sub-Investigator: Lars Kloecker, Dr. med.
Deutsches Herzzentrum Berlin, Abt. angeborener Herzfehler/Kinderkardiologie	Recruiting
Berlin, Germany, 13353
Contact: Felix Berger, Prof. Dr. med. +49-30-4593-2800 Felix.Berger@charite.de
Contact: Björn Peters, Dr. med. +49-30-4593- peters@dhzb.de
Principal Investigator: Björn Peters, Dr. med.
Sub-Investigator: Mustafa Yegitbasi, Dr. med.
Sub-Investigator: Oliver Miera, Dr. med
Sub-Investigator: Majtaba Zeinollabedini, Dr. med.
Sub-Investigator: Yousof Ghanem, Dr. med.
Sub-Investigator: Boris Jaeckel, Dr. med.
Sub-Investigator: Sarah Eder
Sub-Investigator: Dirk Schneider-Kulla, Dr. med.
Klinik für Pädiatrie mit Schwerpunkt Kinderkardiologie CVK Charité	Recruiting
Berlin, Germany, 13353
Contact: joachim C. Will, Dr. med. +49-30-450-616109 achim.will@charite.de
Contact: Felix Berger, Prof. Dr. med. +49-30-450-516041 felix.berger@charite.de
Principal Investigator: Joachim C Will, Dr. med.
Sub-Investigator: Bernd Opgen-Rhein, Dr. med.
Sub-Investigator: Birgit Franzbach, Dr. med.
Universitätsklinikum RWTH Aachen, Klinik für Kinderkardiologie	Recruiting
Aachen, Germany, 52074
Contact: Hedwig Hoevels-Guerich, PD Dr. med. +49-241-8036-253 hhoevels-guerich@ukaachen.de
Contact: Simone Koester +49-241-8035-578 skoester@ukaachen.de
Principal Investigator: Hedwig Hoevels-Guerich, PD Dr. med.
Sub-Investigator: Simone Koester, Dr. med.
LMU Klinikum Grosshadern, Abt. Kinderkardiologie und Pädiatrische Intensivmedizin	Recruiting
München, Germany, 81377
Contact: Heinrich Netz, Prof. Dr. med. +49-89-7095 ext 3940 Heinrich.Netz@med.uni-muenchen.de
Contact: Robert Dalla Pozza, Dr. med. +49-89-7095 ext 3940 Robert.DallaPozza@med.uni-muenchen.de
Principal Investigator: Heinrich Netz, Prof. Dr. med.
Sub-Investigator: Robert Dalla Pozza, Dr. med.
Universität Rostock, Medizinische Fakultät, Kinder- und Jugendklinik	Recruiting
Rostock, Germany, 18055
Contact: Matthias Peuster, Prof. Dr. 0381 / 494 7201 matthias.peuster@med.uni-rostock.de
Principal Investigator: Matthias Peuster, Prof. Dr.
Sub-Investigator: René Hohn, Dr.
Sub-Investigator: Carola Hesse, Dr.
Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie	Recruiting
Münster, Germany, 48149
Contact: Hans Gerd Kehl, PD Dr. med. 0251-834 7796 kehl@ukmuenster.de
Contact: Sybille Singer, Dr. med 0251 / 834 7773 sybille.singer@uni-muenster.de
Principal Investigator: Hans Gerd Kehl, PD Dr. med.
Sub-Investigator: Sybille Singer, Dr. med.
Asklepios Klinik Sankt Augustin, DKHZ	Recruiting
Sankt Augustin, Germany, 53757
Contact: Peter Zartner, Dr. med. 02241-249650 P.zartner@asklepios.com
Contact: Rolf Kallenberg, Dr. med r.kallenberg@asklepios.com
Principal Investigator: Peter Zartner, Dr. med.
Sub-Investigator: Rolf Kallenberg, Dr. med.
Sub-Investigator: Roland Handke, Dr. med.
Sub-Investigator: Nicole Toussiant-Götz, Dr. med.
Sub-Investigator: Michael Kaestner, Dr. med.
Universitätsklinik Frankfurt, KlinikII: Pädiatrische Kardiologie	Recruiting
Frankfurt am Main, Germany, 60590
Contact: Tobias Schuster, Dr. med. 069-6301-5759 tobias.schuster@kgu.de
Contact: Anoosh Semaeili, Dr. med anoosh.esmaeili@kgu.de
Principal Investigator: Tobias Schuster, Dr. med.
Sub-Investigator: Anoosh Esmaeili, Dr.med.
Univ.-Kinderklinik Tübingen	Recruiting
Tübingen, Germany, 72076
Contact: Matthias Gass, Dr. med. +49-7071-3964712 matthias.gass@med.uni-tuebingen.de
Contact: Christian Apitz, Dr. med. christian.apitz@med.uni-tuebingen.de
Principal Investigator: Matthias Gass, Dr. med.
Sub-Investigator: Christian Apitz, Dr. med.
Universitätsklinikum Erlangen, Kinderkardiologische Abteilung, Kinder- und Jugendklinik	Recruiting
Erlangen, Germany, 91054
Contact: Sven Dittrich, Prof. Dr. med. 09131-8533750 sven.dittrich@kinder.imed.uni-erlangen.de
Contact: Theresa Seeliger, Dr. med. 09131-8535301 theresa.seeliger@med2.imed.uni-erlangen.de
Principal Investigator: Sven Dittrich, Prof. Dr. med.
Sub-Investigator: Theresa Seeliger, Dr. med.
Sub-Investigator: Stefan Zink, Dr. med.
Kinderkardiologische Abteilung der Universitäts-Kinderklinik Hamburg	Recruiting
Hamburg, Germany, 20246
Contact: Thomas S. Mir, PD Dr. med. 040-42803-3718 mir@uke.uni-hamburg.de
Contact: Christian Thiel, Dr. med. 040-42803-3718
Principal Investigator: Thomas S. Mir, PD Dr. med.
Sub-Investigator: Christian Thiel, Dr. med.
Sub-Investigator: Lesa Harring, Dr. med.
Universitätsklinikum Freiburg, Klinik III Päd. Kardiologie	Recruiting
Freiburg, Germany, 79106
Contact: Jochen Grohmann, Dr. med jochen.grohmann@uniklinik-freiburg.de
Contact: Raoul Arnold, Dr. med. raoul.arnold@uniklinik-freiburg.de
Principal Investigator: Jochen Grohmann, Dr. med.
Sub-Investigator: Raoul Arnold, Dr. med.

Sponsors and Collaborators

Competence Network for Congenital Heart Defects

Investigators

Principal Investigator:

Hashim Abdul-Khaliq, Prof. Dr. med.

Competence Network for Congenital Heart Defects

Study ID Numbers:	CARE-CHD (NP4)
Study First Received:	March 21, 2007
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00450684
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices