Cardiac Resynchronization Therapy in Congenital Heart Defects (CARE-CHD)
This study is ongoing, but not recruiting participants.
Sponsor:
Competence Network for Congenital Heart Defects
Information provided by:
Competence Network for Congenital Heart Defects
ClinicalTrials.gov Identifier:
NCT00450684
First received: March 21, 2007
Last updated: June 5, 2012
Last verified: August 2011
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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. 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).
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Heart Defects |
Device: implantation and testing of CRT |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Primary Purpose: Treatment |
| Official Title: | Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects |
Resource links provided by NLM:
Further study details as provided by Competence Network for Congenital Heart Defects:
Primary Outcome Measures:
- Ejection fraction [ 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), incl. VO2,max [ 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: 6 visits ]
- death [ Time Frame: 18 months ]
| Estimated Enrollment: | 55 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
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
Locations
| Austria | |
| AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie | |
| Wien, Austria, A-1090 | |
| Germany | |
| Klinikum der Universität zu Köln, Klinik und Poliklinik für Kinderkardiologie | |
| Köln, North Rhine-Westphalia, Germany, D-50924 | |
| Universitätsklinikum Münster, Kardiologisches Zentrum für Erwachsene mit angeborenen und erworbenen Herzfehlern | |
| Münster, North Rhine-Westphalia, Germany, D-48149 | |
| Universitätsklinikum der Martin-Luther-Universität Halle-Wittenberg | |
| Halle, Saxony-Anhalt, Germany, D-06120 | |
| Universitätsklinikum Aachen / AÖR, Klinik für Kinderkardiologie | |
| Aachen, Germany, D-52074 | |
| Herz- und Diabeteszentrum NRW, Klinik für Angeborene Herzfehler | |
| Bad Oeynhausen, Germany, D-32545 | |
| Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler und Kinderkardiologie | |
| Berlin, Germany, D-13353 | |
| Otto-Heubner-Centrum für Kinder- und Jugendmedizin, Klinik für Pädiatrie mit Schwerpunkt Kinderkardiologie CVK Charité | |
| Berlin, Germany, D-13353 | |
| Zentrum fuer Elektrophysiologie und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie | |
| Bremen, Germany, D-28227 | |
| Universitätsklinikum Erlangen, Kinderkardiologische Abteilung, Kinder- und Jugendklinik | |
| Erlangen, Germany, D-91054 | |
| Klinikum der Johann-Wolfgang-Goethe-Universität Zentrum der Kinderheilkunde und Jugendmedizin, Klinik für Kinderheilkunde II mit dem Schwerpunkt Pädiatrische Kardiologie | |
| Frankfurt am Main, Germany, D-60590 | |
| Universitätsklinikum Freiburg Zentrum für Kinder- und Jugendmedizin, Klinik III: Angeborene Herzfehler / Pädiatrische Kardiologie | |
| Freiburg, Germany, D-79106 | |
| Universitäres Herzzentrum Hamburg, Klinik und Poliklinik für Kinderkardiologie | |
| Hamburg, Germany, D-20246 | |
| Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie | |
| Homburg/Saar, Germany, D-66421 | |
| Herzzentrum Leipzig, Klinik für Kinderkardiologie | |
| Leipzig, Germany, D-04289 | |
| Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler | |
| München, Germany, D-80336 | |
| LMU Klinikum Grosshadern, Abt. Kinderkardiologie und Pädiatrische Intensivmedizin | |
| München, Germany, D-81377 | |
| Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie | |
| Münster, Germany, D-48149 | |
| Asklepios Klinik Sankt Augustin, Deutsches Kinderherzzentrum, Abt. Kardiologie / Angeborene Herzfehler | |
| Sankt Augustin, Germany, D-53757 | |
| Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin | |
| Tübingen, Germany, D-72076 | |
Sponsors and Collaborators
Competence Network for Congenital Heart Defects
Investigators
| Principal Investigator: | Prof. Hashim Abdul-Khaliq, MD | Competence Network for Congenital Heart Defects |
More Information
Additional Information:
No publications provided
| Responsible Party: | Competence Network for Congenital Heart Defects |
| ClinicalTrials.gov Identifier: | NCT00450684 History of Changes |
| Other Study ID Numbers: | CARE-CHD |
| Study First Received: | March 21, 2007 |
| Last Updated: | June 5, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |
ClinicalTrials.gov processed this record on May 16, 2013