Eligibility NCT00564993 Tetralogy of Fallot Inclusion Criteria Exclusion Criteria pregnancy or lactation Yes
No
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) Yes
No
any diseases or impairment that, in the opinion of the investigator, would justify to exclude a subject from participation Yes
No
substance abuse (alcohol, medicines, drugs) Yes
No
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 Yes
No
insufficient compliance Yes
No
disagreement with storage & transfer of anonymized disease data within this study. Yes
No
Persons who are detained officially or legally to an official institution Yes
No
contraindication against pharmacological stress testing (ventricular tachycardia or severe arrhythmia, profound pulmonary stenosis and hypertension of the pulmonary artery) Yes
No
Coronary artery disease (CAD) Yes
No
atrial fibrillation or flutter Yes
No
DORV (if there is another VSD than subaortic) Yes
No
associated severe heart defects Yes
No
associated other severe (=hemodynamic significantly) valvular defects except for pulmonary insufficiency Yes
No
Other clinically relevant diseases, such as malignant tumour or florid diseases (as considered by the investigating physician) Yes
No
MRI contraindication, e.g. cardiac pacemaker, implanted neurostimulators and other magnetisable foreign bodies Yes
No
Patient is not able to perform spiroergometry (bicycle/treadmill) or existing contraindications Yes
No
Patients with Type I or II diabetes Yes
No
prohibited concomitant medication: MAO-inhibitors Yes
No
Treatment with beta- or alpha-blocker Yes
No
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) Yes
No
Anticoagulation treatment (risk-benefit decision by the investigating physician, as there may be additional inhibition of platelet aggregation with dobutamine) Yes
No
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 Yes
No
all contraindications against the study medication described in the SMPC Yes
No
