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 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT05683067
Eligibility Criteria:
Inclusion Criteria:
* Patients operated for Fontan procedure or other congenital heart conditions
* Patients ≥ 16 - 50 years of age
* Participant/Parents/Guardian or legal representative willing and able to give Informed Consent for participation in the study
* Able (in the Investigators opinion) and willing to comply with all study requirements
Exclusion Criteria:
* Low blood pressure (90/60 mmHg with symptoms or on intravenous inotropes for maintenance of blood pressure)
* Raynaud's disease
* Autoimmune diseases
* Down's syndrome as they have lower risk for vascular anomalies compared with the general population and may have different microvasculature
* Treatment with sympathomimetic drugs
* Atrial fibrillation or any other arrhythmia which might interfere with vascular function assessments.
* Documented peripheral vascular disease
* Skin disorders such as psoriasis or significant eczema
* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
* Tremor or Inability to keep the hand still for 20 minutes.
Note: Patients treated with angiotensin converting enzyme inhibitors or angiotensin receptor inhibitors, beta blockers, vasodilators, diuretics and digoxin will be included in the study as the majority of Fontan survivors are taking one or more of these drugs for optimization of their circulation or for symptom management. Patients treated with anticoagulants and antiplatelets will be included in the study.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
50 Years
Study:
NCT05683067
Study Brief:
Protocol Section:
NCT05683067