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 @ 3:02 PM
Ignite Modification Date:
2025-12-24 @ 3:02 PM
NCT ID:
NCT06260059
Eligibility Criteria:
Inclusion Criteria:
* Diagnoses of Congenital Heart Disease
* Age 18+
* ACHD level of structural complexity II or III
* Recent (\<6 months) decrease in systemic Ejection Fraction (confirmed by cardiac Echocardiogram, Computed Tomography or cMRI) to EF \< 60%
* Recent decrease in systemic ejection fraction confirmed by cardiac Echo, CT or MRI by \> 5% in the last 6 months or less.
* Must be able to complete neurocognitive assessments on a handheld computer.
Exclusion Criteria:
* Diagnosed with Diabetes
* Contraindication to Jardiance/Entresto or any heart failure medication (per guideline-directed therapy, 2022).
* Previous therapy with Jardiance at \<4 weeks
* Glomerular Filtration Rate \<20
* Pregnancy, breastfeeding, or planning to become pregnant in the coming year
* History of liver disease - including non-alcoholic fatty liver disease (NAFLD) and cirrhosis
* History of inborn error(s) of metabolism (including but is not exclusive of Glycogen storage disease type 1)
* Glucose-galactose malabsorption, familial hyperinsulinism, maple syrup urine disease,
* Gaucher disease,
* Tay-Sachs disease,
* Mucolipidosis IV,
* Niemann-Pick disease,
* Type A mitochondrial disease,
* Metabolic disorders related to glucose metabolism
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06260059
Study Brief:
Protocol Section:
NCT06260059