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 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
NCT ID:
NCT04908657
Eligibility Criteria:
Inclusion Criteria:
1. Patients age ≥ 12 years with anatomic and/or functional univentricular heart receive Fontan procedure followed at our institute (including the patients with heart failure or pregnancy).
2. Patients without taking organic nitrates and not allergic to Sildenafil.
Exclusion Criteria:
1. The patients cannot safely receive MRI examination, including patients with severe renal dysfunction, or after pacemaker or implantable cardioverter defibrillator implantation.
2. Patients having known liver disease (such as viral hepatitis, alcoholic liver disease, etc.) other than FALD.
3. Patients are under sildenafil or any pulmonary vasodilator therapy for lowering pulmonary resistance, or have been using any of these medications in recent 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04908657
Study Brief:
Protocol Section:
NCT04908657