Recruiting

SGLT2I

Sponsor:

Anita Saraf

Code:

NCT06260059

Conditions

Adult Congenital Heart Disease

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Empagliflozin 10 MG

Placebo

Study Details

Brief summary:

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).

Conditions

Adult Congenital Heart Disease

Heart Failure

Study ID

NCT06260059

Start date

Sep 17, 2024

Status verified date

Oct, 2025

Completion date

Jun 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Empagliflozin 10 MG

Empagliflozin 10 mg daily will be administered for 1 year. The patient and the PI will be blinded (unaware) of the group they are assigned to.

placebo comparator: Placebo

Placebo for 1 year

Interventions

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

Placebo

To patients randomized to the placebo group, a placebo pill will be given

Primary outcome measure

  • Change in Ejection fraction (EF) [ Time Frame: Change from baseline in ejection fraction at 1-year ]
  • Change in Myocardial characteristics (T1 mapping of cMRI) [ Time Frame: Change from baseline in T1 mapping at 1-year ]
  • Change in Myocardial characteristics (Global strain on MRI) [ Time Frame: Change from baseline of global strain on MRI at 1 year ]
  • Change in Myocardial characteristics (Global strain on echocardiogram) [ Time Frame: Change from baseline of global strain on echocardiogram at 1 year ]
  • Change in functional exercise capacity of participants. [ Time Frame: Change from baseline of exercise capacity at 1-year ]
  • Number of Participants Hospitalized for Cardiac Reasons or heart transplantation [ Time Frame: Cardiac hospitalizations or transplantation at 1 year. ]
  • Number of Deaths [ Time Frame: Number of deaths at 1 year ]

Central Contacts and Locations

Central contacts

Anita Saraf, MD, PhD

4128648661sarafap@upmc.edu

Morgan Hindes

mhindes@chp.edu

Locations

Magee Women's Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Anita Saraf, MD, PhD

saraf@pitt.edu

Presbyterian Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Anita Saraf, MD, PhD

saraf@pitt.edu

Children's Hospital of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Anita Saraf, MD,PhD

saraf@pitt.edu

More Information

Sponsor

Anita Saraf

Last update posted

Oct 6, 2025

Last verified

Oct, 2025

Keywords

  • congenital heart disease
  • reduced exercise capacity
  • decreased cardiac function

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anita Saraf on 2025-10-06.