Description:

ODM derived from http://clinicaltrials.gov/show/NCT00564993

Link:

http://clinicaltrials.gov/show/NCT00564993

Keywords:
Versions (3) ▾
  1. 12/10/13
  2. 4/15/14
  3. 8/11/14
Uploaded on:

August 11, 2014

DOI:
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License:
Creative Commons BY 4.0
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Eligibility NCT00564993 Tetralogy of Fallot

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age at least 14 Years
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
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
contraindication against pharmacological stress testing (ventricular tachycardia or severe arrhythmia, profound pulmonary stenosis and hypertension of the pulmonary artery)
Coronary artery disease (CAD)
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