drugset / Trial / NCT06507657

Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure

NCT06507657

Phase 0 Recruiting 80 enrolled University of Minnesota
RandomizedParallel-groupDouble-blindTreatment

Summary

Sodium-glucose cotransporter 2 inhibitors (SGLT2i) reduce CVD events, including incident HF. SGLT2 is a glucose transport protein in the kidneys. Inhibition of this protein results in glucosuria and lower serum blood sugar. The SGLT2i medications were initially approved to treat type 2 diabetes (T2D). In 2015, Zinman et al. published the first large randomized clinical trial (RCT) demonstrating a lower composite CVD outcome in adults with T2D treated with empagliflozin compared to placebo (HR 0.85, 95% CI 0.74-0.99). In the specific case of empagliflozin, the hazard ratio was 0.75 (95% CI 0.65-0.86) for HFrEF 8 and 0.79 (95% CI 0.69-0.90) for HFpEF using a treatment dose of 10mg daily. The purpose of this placebo-controlled, double-blinded, randomized pilot study is to investigate the effect of empagliflozin on left atrial (LA) function in 80 patients who are at risk for heart failure. Participants will be randomized 1:1 to either intake of a 10mg empagliflozin oral tablet or a matching placebo once daily.

Timeline

Start
2024-12-12
Primary completion
2029-01-15
Completion
2029-01-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Empagliflozin Small molecule 10 mg Oral

Indications