Cardiac imaging under dobutamine stress for early assessment of right ventricular function in patients with tetralogy of Fallot and pulmonary regurgitation

INTERVENTION: Pharmaceutical Form: Intravenous infusion INN or Proposed INN: Dobutamine Concentration unit: µg/kg microgram(s)/kilogram Concentration type: range Concentration number: 10‐20 CONDITION: Fallot tetralogy late after repair with marked pulmonary valve incompetence PRIMARY OUTCOME: Main Objective: The main objective of this trial is to define new cardial functional parameters of early right cardial insufficiency by pre‐ and postoperative characterisation of right heart function with a Dobutamine stress MRI compared to routine cardiac MRI; ; Primary end point(s): ‐ analysis with ANOVA for follow‐up measurements with determinants of regular and stress MRI to compare group A with group B, (resp.) comparision both visits group A Secondary Objective: Secondary objectives of this trial are:; ‐ to define new cardial functional parameters of early right cardial insufficiency by pre‐ and postoperative characterisation of right heart function with a Dobutamine stress echocardiogram. Correlation to routine cardiac MRI and a Dobutamine stress MRI.; ; ‐ to define new cardial functional parameters of early right cardial insufficiency by pre‐ and postoperative characterisation of right heart function with a tissue Doppler echocardiogram and three‐dimensional echocardiography. Correlation to routine cardiac MRI and a Dobutamine stress MRI.; ; ‐ to evaluate mortality, morbidity, pulmonary function, objective exercise tolerance, life‐quality and prevalence of cardiac arrhythmia after pulmonary valve replacement; INCLUSION CRITERIA: specific: • the patient/ his parents got a consent form and agreed to a informed consent for this cinical trial • negative pregnancy test • no participation in an other medical trial 4 weeks before and during this trial specific • Fallot tetralogy after repair group A (n = 45): youth = 14 years or adult patients after repair of fallots tetralogy, with planed pulmonary valve replacement due relevant pulmonary insufficiency Group B (n = 35): youth = 14 Jahre or adult patients after repair of fallots tetralogy with good results after repair with good right heart function Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range