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

NCT06260059 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The Pittsburgh Foundation

    collaborator OTHER
  • Anita Saraf

    lead OTHER

Principal Investigators

  • Anita Saraf, MD, PhD · Assistant Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-17
Primary Completion
2026-12-31
Completion
2027-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06260059 on ClinicalTrials.gov