Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2I) in Adult Patients with Congenital Heart Disease

Launched by ANITA SARAF · Feb 13, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how well a new heart failure medication called Empagliflozin (brand name Jardiance) works for adults who have congenital heart disease (a heart condition present at birth). The study aims to see if this medication can help improve heart function in patients who have experienced a recent decline in their heart's ability to pump blood, known as ejection fraction. Researchers are currently recruiting participants aged 18 and older who have specific types of congenital heart disease and have experienced a drop in heart function in the last six months.

To be eligible for the trial, participants must have a confirmed diagnosis of congenital heart disease and a recent decrease in their heart function, as shown by tests like echocardiograms or MRIs. However, individuals with diabetes, certain liver diseases, or specific metabolic disorders cannot participate. Those who join the study can expect to complete some assessments on a handheld computer and receive close medical monitoring throughout the trial. This study is important as it could provide new insights into treating heart failure for adults with congenital heart disease, potentially offering them better care options in the future.

Gender

ALL

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