Tests empagliflozin's effect on heart filling in adults at risk for heart failure
Tests empagliflozin against a placebo in adults over 60 with high blood pressure.
Plain-language title generated from the registry record
Registry title: Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
Key facts
- Where
- Minneapolis, United StatesSee the site
- Phase
- Early phase 1
Where in United States
- University of MinnesotaMinneapolis, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Minnesota
- Trial code
- NCT06507657
- Record updated
- 20 October 2026
- Original description
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.Read full original descriptionShow less
Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
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.
Inclusion: Age >60 years of age; Clinical diagnosis of hypertension; Body mass index ≥30kg/m2; We will screen for participants with an echocardiogram within 60 days of the baseline visit.
Exclusion: Current treatment with SGLT2 inhibitor, GLP1 agonist, or DPP4 inhibitors; Participants in whom coronary revascularization by either PCI or bypass surgery is being contemplated within 6 months, or who have undergone revascularization in the prior 2 months; Any malignancy not considered cured (except basal cell carcinoma of the skin). A participant is considered cured if there has been no evidence of cancer recurrence for the 5 years prior to screening; Participants who have participated in studies of an investigational drug or device within 30 days prior to the screening visit; Major surgery (major according to the investigator's assessment) performed within 90 days prior to Visit 1 or scheduled major elective surgery within 90 days after Visit 1; Moderate or severe valve disease on echocardiogram; History of genitourinary infection; Significant allergy or known intolerance to SGLT2 inhibitors or any ingredient in the formulations; Participants currently experiencing any clinically significant or unstable medical condition that might limit their ability to complete the study, or to comply with the requirements of the protocol, including: dermatologic disease, hematological disease, pulmonary disease, hepatic disease, gastrointestinal disease, genitourinary disease, endocrine disease, neurological disease, and psychiatric disease; Unstable coronary syndromes; History of type 1 or type 2 diabetes mellitus by medical history or hemoglobin A1c >7.0% at Visit 1; Any LVEF measure of ≤40% on past echocardiogram; eGFR <60 ml/min/1.73 m2 at Visit 1; Female participants who are pregnant, lactating, or of child bearing potential; Clinical diagnosis of HFpEF or HFrEF by participant self-report or documented in the electronic health record; Inadequate quality echocardiographic images; Non-English speaking individuals.