NCT06260059 · Anita Saraf
Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2I) in Adult Patients with Congenital Heart Disease
(EmpaCHD)
What this study is about
The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).
View original scientific description
The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD).
Interventions
DRUG
Empagliflozin 10 MG
Patient will be given 10 mg of Empagliflozin if randomized to the drug arm or will receive placebo drug for 1 year
DRUG
Placebo
To patients randomized to the placebo group, a placebo pill will be given
Primary outcome measures
Change in Ejection fraction (EF)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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 transplantation
Time frame: Cardiac hospitalizations or transplantation at 1 year.
Hospitalization for cardiac reasons or heart transplantation
Number of Deaths
Time frame: Number of deaths at 1 year
Number of patients who died during the study from all causes
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Diagnoses of Congenital Heart Disease
- 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)
Where
- Pittsburgh, Pennsylvania
Collaborators
The Pittsburgh Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2025 · Source of record for eligibility and locations