Fallot tetralogy late after repair with marked pulmonary valve incompetence
Conditions
Interventions
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Dobutamine
Concentration unit: µg/kg microgram(s)/kilogram
Concentration type: range
Concentration number: 10-20
Sponsors
Deutsche Herzzentrum Berlin, Kompetenznetz Angeborene Herzfehler
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: - pregnancy or lactation - childbearing women without sufficient contraception - diseases which exclude the patient the patient from the participation after evaluation through the treating md - abuse of alcohol, medecine or addictive drugs - other medical, psychological or social conditions, which complicate -raise the risk for the treatment of the patient (trisomia 21, psychiatric diseases) - lack of compliance or expected lack of ability to comply - lack of willingness to save and transfer pseudonymized data in course of the trial - Persons who are detained officially or legally to an official institute -contra-indications against pharmacological treatment like ventricular tachykardia or similar, pulmonary valve stenosis or pulmonary hypertension - present or high risk of coronary heart disease - present or known atrial fibrilation or flutter - double-outlet right ventrical - associated servere heart failures - associated servere valve failures, exept pulmonary valve insufficiancy - other relevant tumor or active diseases - absolut conta-indications for MRI, like pacemaker - patient unable to participate in stress tests - patients with contra-indications for the treatment with dobutamine - patients with diabetes - patients with concomitant containdicant treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;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 ;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 | — |
Countries
Germany
Outcome results
None listed