Actively Recruiting

Early Phase 1
Age: 60Years +
All Genders
NCT06507657

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

Led by University of Minnesota · Updated on 2025-10-03

80

Participants Needed

1

Research Sites

213 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age greater than 60 years
  • Clinical diagnosis of hypertension
  • Body mass index of 30 kg/m2 or higher
  • Echocardiogram performed within 60 days before the baseline visit
Not Eligible

You will not qualify if you...

  • Female participants who are pregnant, lactating, or able to become pregnant
  • History of type 1 or type 2 diabetes or hemoglobin A1c over 7.0% at first visit
  • Clinical diagnosis of heart failure with preserved or reduced ejection fraction
  • Left ventricular ejection fraction of 40% or lower on past echocardiogram
  • Moderate or severe heart valve disease
  • History of genitourinary infection
  • Estimated glomerular filtration rate below 60 ml/min/1.73 m2 at first visit
  • Current treatment with SGLT2 inhibitors, GLP1 agonists, or DPP4 inhibitors
  • Planned coronary revascularization within 6 months or revascularization within prior 2 months
  • Known allergy or intolerance to SGLT2 inhibitors or study ingredients
  • Unstable or significant medical conditions that might limit study completion or compliance
  • Any cancer not considered cured within past 5 years (except basal cell skin cancer)
  • Participation in investigational drug or device studies within 30 days prior to screening
  • Poor quality echocardiographic images
  • Unstable coronary syndromes
  • Major surgery within 90 days before or planned within 90 days after first visit
  • Non-English speaking individuals

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

University of Minnesota

Minneapolis, Minnesota, United States, 55414

Actively Recruiting

Loading map...

Research Team

J

Julie Dicken, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here