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

NCT ID: NCT06260059

Last Updated: 2025-10-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2027-06-01

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).

Detailed Description

As CHD adolescents transition to adulthood, it is becoming evident that in addition to their structural cardiac abnormalities, they also have an intrinsic disease of the heart muscle which manifests as abnormal heart rhythm (arrhythmia) and decreased function (heart failure).

The lifesaving cardiac surgeries during childhood can also contribute to this dysfunction (cardiomyopathy). Hence, patients with CHD require multiple interventions and close clinical follow-up throughout their life. Currently, there are over 2.5 million CHD patients in the U.S. alone, and an additional 40,000 babies are born with CHD every year. Up to 50% of these patients require inpatient hospital care at some point due to their cardiomyopathy.

High-risk ACHD patients do not receive treatment until they present with heart failure or arrhythmia, at which time there is significant evidence of myocardial disease and dysfunction.

Empagliflozin (Jardiance) is an FDA-approved drug that significantly reduces hospitalization risk and cardiovascular death in adult patients with non-CHD heart failure. Studies show that Empagliflozin protects the heart from inflammation, and preliminary evaluation of Empagliflozin in symptomatic ACHD patients showed improved cardiac function and a reduction in heart failure including decreased shortness of breath and increased functional capacity. Empagliflozin as a preventative therapy may delay the onset of comorbidities by reducing inflammation in ACHD patients.

The study hypothesis is that the administration of once-a-day oral Jardiance (Empagliflozin) medication for one year reduces arrhythmia and cardiomyopathy and lowers serum circulating inflammatory factors and improves neurocognitive outcomes in susceptible ACHD patients.

1. Does Empagliflozin 10 milligrams (MG) improve cardiac function in ACHD patients

2. Does Empagliflozin 10 milligrams (MG) improve functional status in ACHD patients

Conditions

Adult Congenital Heart Disease; Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Empagliflozin 10 MG

Intervention Type: DRUG

Patient will be given 10 mg of Empagliflozin if randomized to the drug arm or will receive placebo drug for 1 year

Placebo

Placebo for 1 year

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Jardiance, Empagliflozin; Placebo Drug

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Pittsburgh Foundation

OTHER

Sponsor Role: collaborator

Anita Saraf

OTHER

Sponsor Role: lead

Responsible Party

Anita Saraf

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Anita Saraf, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistant Professor

Locations

Magee Women's Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Presbyterian Hospital

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Anita Saraf, MD, PhD

Role: CONTACT

sarafap@upmc.edu

4128648661

Morgan Hindes

Role: CONTACT

mhindes@chp.edu

Facility Contacts

Anita Saraf, MD, PhD

Role: primary

saraf@pitt.edu

Anita Saraf, MD, PhD

Role: primary

saraf@pitt.edu

Anita Saraf, MD,PhD

Role: primary

saraf@pitt.edu

Other Identifiers

Pitt2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY23070148

Identifier Type: -

Identifier Source: org_study_id