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Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure | Clinical Trials | Clareo Health

RECRUITINGEARLY_PHASE1

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

NCT06507657•University of Minnesota

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

Age

60 - No limit years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (1)

University of Minnesota

Minneapolis, Minnesota, United States

Key Dates

Start Date

December 12, 2024

Primary Completion Date

January 15, 2029

Completion Date

January 15, 2029

Last Updated

October 3, 2025

Enrollment

ESTIMATED participants

Conditions

HypertensionCardiovascular Diseases

Interventions

empagliflozin

DRUG

Placebo tablet

DRUG

Contacts

Julie Dicken, RN

CONTACT

dicke022@umn.edu

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RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Natural History of Noncirrhotic Portal Hypertension

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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