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 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT03965351
Eligibility Criteria:
Inclusion Criteria:
1. ≥ 12 years old
2. Single ventricle congenital heart disease status post Fontan procedure.
3. Impaired ventricular function as assessed by preexisting echocardiographic studies and any available MRI studies.
1. LV inclusion criteria: Ejection fraction by cMRI or echo assessment of \<50% or moderate to severe dysfunction.
2. RV inclusion criteria: Ejection fraction by cMRI of \<45% or moderate to severe dysfunction. Or, given the ASE recommendation to avoid use of 2-D imaging quantification for assessment of right ventricular systolic function, a peak global longitudinal strain value as assessed by a single reviewer with a value greater than -17% will also be included. Peak global longitudinal strain analysis will be performed for all eligible single right ventricles noted by subjective echo reports to have abnormal systolic function if no qualifying cardiac MRI assessment of ejection fraction is available.
Exclusion Criteria:
1. Clinically unstable or ongoing illness.
2. Evidence of untreated Fontan pathway obstruction.
3. Presence of uncontrolled arrhythmias.
4. Evidence of moderate or greater atrioventricular valve regurgitation.
5. Pregnancy.
6. History of sulfonamide allergy
7. Known G6PD deficiency
8. Patients on certain drugs that have potentially dangerous interactions with probenecid: doripenem, zalcitabine, deferiperone, citalopram, methotrexate, ciprofloxacin, amoxicillin, cefprozil, cefpodoxime, cefotaxime, meropenem, ertapenem, valganciclovir, ganciclovir, ziovudine ketorolac, cefdinir, cephalexin, dapsone, indomethacin, and piperacillin.Each subject's medication list will be reviewed prior to study participation.
9. Impaired renal function as defined by a GFR \< 60mL/min/1.73 m2 within the last year.
10. Patients at a higher risk for arrhythmia including those with a prior history of arrhythmia including atrial and ventricular dysrhythmia or those on established anti-arrhythmic therapy.
11. Admission to the hospital due to a clinically significant arrhythmia within the previous month.
12. Greater than moderate atrioventricular regurgitation as denoted on most recent echo report.
13. Patients with atrio-pulmonary Fontan
14. Currently enrolled in an interventional drug trial or completed an interventional drug trial within the past 30 days.
15. Not appropriate for MRI screening due to having an implanted device.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT03965351
Study Brief:
Protocol Section:
NCT03965351