Cardiac Function Under Stress for Early Detection of the Right Ventricular Insufficiency After Repair of Tetralogy of Fallot

Inclusion Criteria:

• Written informed consent of the patient or patient's legal representatives
• No participation in another AMG driven study within the past 4 weeks or during the whole duration of this study

• Patients with Tetralogy of Fallot after corrective surgery

  • group A (n=45): Adolescents ≥ 14 years or adults with Tetralogy of Fallot after corrective surgery and necessary re-intervention (pulmonary valve replacement because of pulmonary insufficiency
  • group B (n=35): Adolescents ≥ 14 years or adults with Tetralogy of Fallot after corrective surgery and good result of repair and good right ventricular function

Exclusion Criteria:

Non-specific

• pregnancy or lactation
• women of child-bearing age who are sexually active without practising highly effective methods of contraception (a urine/serum pregnancy test may be requested at the discretion of the investigator)
• any diseases or impairment that, in the opinion of the investigator, would justify to exclude a subject from participation
• substance abuse (alcohol, medicines, drugs)
• other medical, psychological or social circumstances that would adversely affect a patient's ability to participate reliably in the study or increase the risk to themselves or others if they participated
• insufficient compliance
• disagreement with storage & transfer of anonymized disease data within this study.
• Persons who are detained officially or legally to an official institution

Specific

• contraindication against pharmacological stress testing (ventricular tachycardia or severe arrhythmia, profound pulmonary stenosis and hypertension of the pulmonary artery)
• coronary heart disease
• atrial fibrillation or flutter
• DORV (if there is another VSD than subaortic)
• associated severe heart defects
• associated other severe (=hemodynamic significantly) valvular defects except for pulmonary insufficiency
• Other clinically relevant diseases, such as malignant tumour or florid diseases (as considered by the investigating physician)
• MRI contraindication, e.g. cardiac pacemaker, implanted neurostimulators and other magnetisable foreign bodies
• Patient is not able to perform spiroergometry (bicycle/treadmill) or existing contraindications
• Patients with Type I or II diabetes
• prohibited concomitant medication: MAO-inhibitors
• Treatment with beta- or alpha-blocker
• Treatment with high doses of ACE-inhibitors or inhibitors of the AT- receptor and permanent treatment with nitrates (in the investigating physician's risk assessment)
• Anticoagulation treatment (risk-benefit decision by the investigating physician, as there may be additional inhibition of platelet aggregation with dobutamine)
• Treatment with diuretics (risk-benefit decision by the investigating physician, as there may be enhancement of the hypokalemia by administration of dobutamine); if necessary verification of the serum K+ -level before exposure to dobutamine
• all contraindications against the study medication described in the SMPC