HP 4.3 Cardiac function under stress for the early detection of right ventricular failure after corrective surgery for Tetralogy of Fallot (starting November 2007)

Multi-centric, prospective, open, non-randomised

80 patients

Duration of study: 4th quarter 2007 to 1st quarter 2013
End date for recruitment: June 2011

Definition of new cardiac function parameters to evaluate early right ventricular failure (or right ventricular remodelling) based on the preoperative and postoperative characterisation of right ventricular function using dobutamine stress MRI (DSMR), as compared to conventional volumetric MRI cardiac scans.

• Definition of new cardiac function parameters to evaluate early right ventricular failure (or right ventricular remodelling) based on the preoperative and postoperative characterisation of right ventricular function using dobutamine stress echocardiography (DSE), and establishing a correlation with MRI scans of cardiac function and dobutamine stress MRI.
• Definition of new cardiac function parameters to evaluate early right ventricular failure (or right ventricular remodelling) based on the preoperative and postoperative characterisation of right ventricular function using myocardial tissue Doppler and 3D echo volumetric testing, and establishing a correlation with MRI scans of cardiac function and dobutamine stress MRI.
• Documentation of mortality, morbidity, pulmonary function and objectively assessed exercise tolerance, quality of life and prevalence of arrhythmias associated with pulmonary valve replacement.

• Tetralogy of Fallot subsequent to corrective surgery:
  
  
• Group A:
  Adolescents aged 14 years and older or adult patients with corrected Tetralogy of Fallot requiring re-intervention and pulmonary valve replacement due to clinically relevant pulmonary insufficiency (n=45)
• Group B:
  Adolescents aged 14 years and older or adult patients with corrected Tetralogy of Fallot whose response to corrective surgery has been positive and who have a good right ventricular function (n=35).

• Contraindications to pharmacological stress such as ventricular tachycardia or similarly
  severe forms of arrhythmia
• Extensive pulmonary stenosis (ratio of pulmonary vascular to systemic pressure at rest > 60%)
• Pulmonary arterial hypertension
• DORV (if VSD not located in the subaortic region)
• Other associated severe heart defects
• Presence of other clinically relevant diseases such as malignant neoplasm or florid diseases (unless judged acceptable by the principal investigator)
• Absolute contraindication of MRI, such as presence of a heart pacemaker
• Signs of existing coronary artery disease or high risk factors in this respect (as assessed by the principal investigator)
• Presence of atrial fibrillation or flutter, or documented recalled episodes of such phenomena
• Other associated severe (= haemodynamically significant) valvular heart defect other than pulmonary valve insufficiency
• Long-term treatment with alpha or beta receptor blockers
• High-dose therapy with ACE inhibitors, AT receptor blockers or long-term treatment with nitrate-based drugs
• Contraindication of ergospirometry (treadmill/bicycle)
• Diabetes mellitus type I or II
• Contraindication of dobutamine treatment

MAO inhibitors

Group A: 2 visits, Group B: 1 visit

€2,500 per patient in Group A (2 visits)
€1,000 per patient in Group B (only 1 visit)

A number of clinics and heart centres all over Germany are taking part in the study. An up-to-date list of these participants can be found here …