Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-25 @ 1:25 AM
NCT ID:
NCT00564993
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Study:
NCT00564993
Study Brief:
Protocol Section:
NCT00564993