University of Minnesota
Minneapolis, Minnesota, 55414, United States
Location status: Recruiting
NCT Number: NCT06507657
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.
Interested in participating?
Request Info60 year and older
All sexes
Interventional
Early Phase 1
Minneapolis, Minnesota, 55414, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 9 months
LA function will be quantified by assessing LA reservoir, conduit, and contractile strain with 2DE at baseline and 9 months.
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 9 months
Time frame: 3 months and 9 months
Time frame: 3 months and 9 months
Time frame: 3 months and 9 months
Time frame: 1, 3 and 9 months
Contact information is provided by the study sponsor or research team.
University of Minnesota
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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