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:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT01292551
Eligibility Criteria:
Inclusion Criteria:
* TCPC operated
* Age \> 15 years old
* Clinical stability \> 3 months, evaluated by investigator from clinical record
* For women: Negative s-hCG and use of contraception
Exclusion Criteria:
* Severe heart failure (NYHA-class IV)
* Oxygen saturation \< 85 % at rest
* Pre-existing liver condition (transaminases 2x \> reference)
* Renal failure (creatinin \> 150 mmol/l)
* Obstruction of TCPC circulation
* History of work induced severe arrhythmia
* Systolic blood pressure below 80% of reference (BT \< 88 mmHg)
* Use of any of following drugs: Fluconazol, Ketoconazole, CiclosporinA, Lopinavir, Ritonavir, Rifampicin, Carbamazepin and Phenytoin
* Significant extra-cardiac condition e.g. neurological impairment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT01292551
Study Brief:
Protocol Section:
NCT01292551