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
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
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
-
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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