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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT04764305
Eligibility Criteria:
Inclusion Criteria:
* written informed consent of participants
* age at testing of ≥18 years
* 8 h fasting before blood sampling
* Fontan circulation (patients)
* biventricular heart without structural or functional abnormality (controls)
Exclusion Criteria:
* Protein losing enteropathy (PLE) (patients are defined as "PLE positive" if there is/are serum protein \<5g/dL and serum albumin \<3g/dL (duration for more than 3 months and exclusion of other causes for hypoproteinemia) and documented enteric protein loss: faecal alpha-1-antitrypsin ≥400 µg/g
* medication directly affecting metabolic state, such as cholesterol-lowering agents, or haemodynamic state, such as beta-blockers or sildenafil, with the exception of angiotensin converting enzyme inhibitors, diuretics, and anticoagulants
* atrial or ventricular arrhythmia
* coronary artery disease (history of myocardial infarction, myocardial revascularisation, percutaneous coronary intervention, or coronary artery bypass surgery)
* any metabolic disease, such as diabetes mellitus
* malignancy
* obesity (body mass index (BMI) \>25 kg/m2)
* underweight (BMI \< 18 kg/m2)
* renal disease
* inflammatory disease such as acute or chronic infection
* myeloproliferative disorder
* pregnancy or lactation
* malnourishment
* mental handicap not allowing valid consent to participation in the study or CMR
* need of sedation or general anesthesia for CMR
* typical contraindications for performing CMR such as metal-containing mechanical or electronic implants
* claustrophobia
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04764305
Study Brief:
Protocol Section:
NCT04764305