Life sciences · Phase 4 Trial
ClinicalTrials.gov · September 17, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT06260059). This is a study registration, not published results. Lead sponsor: Anita Saraf. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Adult Congenital Heart Disease, Heart Failure. Interventions: DRUG: Empagliflozin 10 MG; DRUG: Placebo. Primary outcome measures: Change in Ejection fraction (EF) , Change from baseline in ejection fraction at 1-year; Change in Myocardial characteristics (T1 mapping of cMRI) , Change from baseline in T1 mapping at 1-year; Change in Myocardial characteristics (Global strain on MRI) , Change from baseline of global strain on MRI at 1 year; Change in Myocardial characteristics (Global strain on echocardiogram) , Change from baseline of global strain on echocardiogram at 1 year; Change in functional exercise capacity of participants. , Change from baseline of exercise capacity at 1-year; Number of Participants Hospitalized for Cardiac Reasons or heart transplantation , Cardiac hospitalizations or transplantation at 1 year.; Number of Deaths , Number of deaths at 1 year. 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).