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NCT Number: NCT00450684

Cardiac Resynchronization Therapy in Congenital Heart Defects

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).

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

AKH Wien, Klinische Abteilung für Pädiatrische Kardiologie, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Ejection fraction

    Time frame: 7 visits

  2. QRS-interval

    Time frame: 7 visits

Secondary outcomes

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

    Time frame: 7 visits

  2. Tissue Doppler echocardiography: dyssynchrony parameters, regional myocardiac function

    Time frame: 7 visits

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

    Time frame: 7 visits

  4. NT pro-BNP

    Time frame: 7 visits

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

    Time frame: 6 visits

  6. Walking distance in 6 minutes

    Time frame: 6 visits

  7. Decrease of hospitalization

    Time frame: 18 months

  8. Decrease of ventricular and atrial arrhythmias

    Time frame: 18 months

  9. Prevention or postponement of heart transplantation

    Time frame: 18 Months

  10. Quality of life

    Time frame: 6 visits

  11. death

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Competence Network for Congenital Heart Defects

Other Gov

Registry information

Official study title

Cardiac Resynchronization Therapy in Heart Failure Patients With Congenital Heart Defects

Acronym: CARE-CHD

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Mar 22, 2007
Registry last updated
Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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