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

NCT06260059 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: STUDY23070148Pitt2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

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

Keywords

congenital heart disease; reduced exercise capacity; decreased cardiac function

Outcome Measures

Primary Outcomes (7)

• Change in Ejection fraction (EF)

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

  Change from baseline in ejection fraction at 1-year

• Change in Myocardial characteristics (T1 mapping of cMRI)

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

  Change from baseline in T1 mapping at 1-year

• Change in Myocardial characteristics (Global strain on MRI)

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

  Change from baseline of global strain on MRI at 1 year

• Change in Myocardial characteristics (Global strain on echocardiogram)

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

  Change from baseline of global strain on echocardiogram at 1 year

• Change in functional exercise capacity of participants.

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

  Change from baseline of exercise capacity at 1-year

• Number of Participants Hospitalized for Cardiac Reasons or heart transplantation

  Hospitalization for cardiac reasons or heart transplantation

  Cardiac hospitalizations or transplantation at 1 year.

• Number of Deaths

  Number of patients who died during the study from all causes

  Number of deaths at 1 year

Secondary Outcomes (6)

• Change in inflammatory serum biomarkers

  Change from baseline of serum biomarkers at 1-year

• Change in functional Neuropsychological Testing

  Change from baseline of neuropsychological testing at 1-year

• Change in New York Heart Association (NYHA) Class

  Change from baseline of NYHA Class at 1-year.

• Change Patient-Reported Outcomes Measurement Information System (PROMIS)

  Change from baseline of PROMIS composite score at 1 year

• Change in Kansas City Cardiomyopathy (KCCQ)

  Change from baseline of KCCQ score at 1 year

Study Arms (2)

Empagliflozin 10 MG

EXPERIMENTAL

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.

Drug: Empagliflozin 10 MG

Placebo

PLACEBO COMPARATOR

Placebo for 1 year

Drug: Placebo

Interventions

Empagliflozin 10 MG DRUG

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

Also known as: Jardiance, Empagliflozin

Empagliflozin 10 MG

Placebo DRUG

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

Also known as: Placebo Drug

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Anita Saraf: lead
• The Pittsburgh Foundation: collaborator

Study Sites (3)

Magee Women's Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Presbyterian Hospital

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital; Heart Failure

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Anita Saraf, MD, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anita Saraf, MD, PhD

CONTACT

4128648661; sarafap@upmc.edu

Morgan Hindes

CONTACT

mhindes@chp.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Group 1: Empagliflozin 10 MG daily Group 2: Placebo

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: February 15, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)