NCT06260059

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

Efficacy of Sodium Glucose Transporter Inhibitor (SGLT2i) in Adult Patients With Congenital Heart Disease

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Anita Saraf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-17
• Primary completion: 2026-12-31
• Completion: 2027-06-01
• First posted: 2024-02-15
• Last updated: 2025-10-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study