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Empagliflozin for Adult Congenital Heart Disease and Heart Failure

This study is looking at whether a drug called Empagliflozin (Jardiance) can help adult patients with congenital heart disease (a heart problem present from birth) who are also experiencing heart failure (when the heart can't pump enough blood). You might be able to join if you are an adult (18+) with congenital heart disease of a certain complexity, and your heart's pumping ability (ejection fraction) has recently decreased. The study will compare Empagliflozin to a placebo (a pill with no active drug) over one year. Researchers will measure changes in your heart's pumping ability and other heart characteristics using MRI scans to see if Empagliflozin is beneficial. The study aims to enroll 40 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive either Empagliflozin or a placebo. It plans to enroll 40 adult participants.
What's involved
Participants will receive either Empagliflozin 10 mg or a placebo for one year. Heart function will be measured at the beginning and after one year using MRI scans.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for one year to measure changes in heart function.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06260059

Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease

Active, Not Recruiting
PHASE4Ages 18+InterventionalTreatment
Anita Saraf
~40 participants
Updated 2026-09-17 on ClinicalTrials.gov
What's tested:Empagliflozin 10 MGPlacebo

At a glance

Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Ejection fraction (EF)
Measured over Change from baseline in ejection fraction at 1-year
+6 more outcomes measured

Conditions

Adult Congenital Heart Disease
Heart Failure

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NCT06260059

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvaniano site contact published

  • Magee Women's Hospital

    Pittsburgh, Pennsylvaniano site contact published

  • Presbyterian Hospital

    Pittsburgh, Pennsylvaniano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Anita Saraf, MD, PhD · PRINCIPAL_INVESTIGATOR · Assistant Professor

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Ejection fraction (EF)Change from baseline in ejection fraction at 1-year

    Cardiac Magnetic Resonance Imaging (cMRI) and echocardiography will be used to measure ventricular function

  • Change in Myocardial characteristics (T1 mapping of cMRI)Change from baseline in T1 mapping at 1-year

    Cardiac Magnetic Resonance Imaging (cMRI) without contrast will be used to measure myocardial characteristics

  • Change in Myocardial characteristics (Global strain on MRI)Change from baseline of global strain on MRI at 1 year

    Cardiac Magnetic Resonance Imaging (cMRI) will be used to measure myocardial characteristics

  • Change in Myocardial characteristics (Global strain on echocardiogram)Change from baseline of global strain on echocardiogram at 1 year

    Echocardiography will be used to measure myocardial characteristics such as global longitudinal strain

  • Change in functional exercise capacity of participants.Change from baseline of exercise capacity at 1-year

    Cardiopulmonary exercise stress testing (CPET) will be used to measure functional change in MVO2, RER, Exercise time, METs, and vitals.

  • Number of Participants Hospitalized for Cardiac Reasons or heart transplantationCardiac hospitalizations or transplantation at 1 year.

    Hospitalization for cardiac reasons or heart transplantation

  • Number of DeathsNumber of deaths at 1 year

    Number of patients who died during the study from all causes