RecruitingEarly Phase 1NCT06507657

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

Sponsor

University of Minnesota

Enrollment

80 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Cardiovascular Diseases Hypertension

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.

Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a diabetes medication called empagliflozin (brand name Jardiance) can improve how the upper left chamber of the heart (the left atrium) works in people who are at high risk of developing heart failure, even if they don't have diabetes. **You may be eligible if...** - You are over 60 years old - You have been diagnosed with high blood pressure (hypertension) - Your body mass index (BMI) is 30 or above (considered obese) - You have had a heart ultrasound (echocardiogram) within the past 60 days **You may NOT be eligible if...** - You are pregnant, breastfeeding, or could become pregnant - You have been diagnosed with type 1 or type 2 diabetes, or have a recent blood sugar (A1c) above 7.0% - You already have a diagnosis of heart failure - Your heart pumping function is significantly reduced (ejection fraction 40% or less) - You have moderate or severe heart valve problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGempagliflozin

intake of a 10mg empagliflozin oral tablet At visit 1, after randomization, participants will be provided with bottles containing enough study pills for 3 months duration at 1 tablet daily. Participants will start the study drug on the morning following Visit 1. At the 3 month follow up visit, participants will be provided with enough study pills to complete the remaining 6 months of the study.

DRUGPlacebo tablet

intake a placebo oral tablet At visit 1, after randomization, participants will be provided with bottles containing enough study pills for 3 months duration at 1 tablet daily. Participants will start the study drug on the morning following Visit 1. At the 3 month follow up visit, participants will be provided with enough study pills to complete the remaining 6 months of the study.