Recruiting
Early Phase 1

Empagliflozin

Sponsor:

University of Minnesota

Code:

NCT06507657

Conditions

Hypertension

Cardiovascular Diseases

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

empagliflozin

Placebo tablet

Study Details

Brief 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.

Conditions

Hypertension

Cardiovascular Diseases

Study ID

NCT06507657

Start date

Dec 12, 2024

Status verified date

Oct, 2025

Completion date

Jan 15, 2029

Anticipated

Primary completion date

Jan 15, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • Female participants who are pregnant, lactating, or of child bearing potential
  • History of type 1 or type 2 diabetes mellitus by medical history or hemoglobin A1c >7.0% at Visit 1
  • Clinical diagnosis of HFpEF or HFrEF by participant self-report or documented in the electronic health record
  • Any LVEF measure of ≤40% on past echocardiogram
  • Moderate or severe valve disease on echocardiogram
  • History of genitourinary infection
  • eGFR <60 ml/min/1.73 m2 at Visit 1
  • 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
  • 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
  • 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
  • Inadequate quality echocardiographic images
  • Unstable coronary syndromes
  • 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.
  • Non-English speaking individuals

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental group

placebo comparator: Placebo group

Interventions

empagliflozin

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.

Placebo 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.

Primary outcome measure

  • change in LA function [ Time Frame: 9 months ]

Central Contacts and Locations

Central contacts

Julie Dicken, RN

dicke022@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Julie Dicken

dicke022@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Oct 3, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2025-10-03.