Cardiac Resynchronization Therapy in Congenital Heart Defects

NCT00450684 | Completed Phase 2

• 1 other identifier: CARE-CHD
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 16

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).

Conditions

Congenital Heart Defects

Outcome Measures

Primary Outcomes (2)

• Ejection fraction

  7 visits

• QRS-interval

  7 visits

Secondary Outcomes (11)

• Echocardiographic standard parameters (e.g. LVIDd. FS, RVIDd)

  7 visits

• Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function

  7 visits

• 3D echocardiography:LV volumes, LVEF, Dyssynchrony index

  7 visits

• NT pro-BNP

  7 visits

• Spiroergometry: performance P (W/kg), incl. VO2,max

  6 visits

Study Arms (2)

Group A

EXPERIMENTAL

Implantation and testing of CRT

Device: Implantation and testing of CRT

Group B

EXPERIMENTAL

IImplantation and testing of CRT

Device: Implantation and testing of CRT

Interventions

Implantation and testing of CRT DEVICE

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).

Group A; Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Competence Network for Congenital Heart Defects: lead

Study Sites (16)

AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie

Vienna, A-1090, Austria

Location

Universitätsklinikum Münster, Klinik für angeborene (EMAH) und erworbene Herzfehler

Münster, North Rhine-Westphalia, D-48149, Germany

Location

Universitätsklinikum Halle (Saale), Universitätsklinik und Poliklinik für Pädiatrische Kardiologie

Halle, Saxony-Anhalt, D-06120, Germany

Location

Uniklinik RWTH Aachen, AÖR, Klinik für Kinderkardiologie

Aachen, D-52074, Germany

Location

Herz- und Diabeteszentrum NRW, Klinik für Kinderkardiologie und angeborene Herzfehler

Bad Oeynhausen, D-32545, Germany

Location

Charité - Universitätsmedizin Berlin, Klinik für Pädiatrie mit Schwerpunkt Kardiologie

Berlin, D-13353, Germany

Location

Deutsches Herzzentrum Berlin, Klinik für Angeborene Herzfehler/Kinderkardiologie

Berlin, D-13353, Germany

Location

Elektrophysiologie Bremen und Herzzentrum Bremen, Abteilung für Angeborene Herzfehler/Kinderkardiologie

Bremen, D-28227, Germany

Location

Universitätsklinikum Erlangen, Kinderkardiologische Abteilung

Erlangen, D-91054, Germany

Location

Universitäts-Herzzentrum Freiburg Bad Krozingen, Zentrum für Kinder- und Jugendmedizin, Angeborene Herzfehler/Pädiatrische Kardiologie

Freiburg im Breisgau, D-79106, Germany

Location

Universitäres Herzzentrum Hamburg, Kinderkardiologie

Hamburg, D-20246, Germany

Location

Universitätsklinikum des Saarlandes, Klinik für Pädiatrische Kardiologie

Homburg/Saar, D-66421, Germany

Location

Deutsches Herzzentrum München, Klinik für Kinderkardiologie und angeborene Herzfehler

München, D-80336, Germany

Location

Universitätsklinikum Münster, Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Kardiologie

Münster, D-48149, Germany

Location

Deutsches Kinderherzzentrum Sankt Augustin, Abt. Kardiologie/Angeborene Herzfehler

Sankt Augustin, D-53757, Germany

Location

Universitätsklinik für Kinder- und Jugendmedizin Tübingen, Abt. Kinderkardiologie, Pulmologie, Intensivmedizin

Tübingen, D-72076, Germany

Location

Related Links

• Related Info

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Hashim Abdul-Khaliq, Prof., MD

  Competence Network for Congenital Heart Defects

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 22, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2012
• Study Completion: September 1, 2013
• Last Updated: October 10, 2014

Record last verified: 2014-10

Locations

AU (1); DE (15)