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

NCT ID: NCT06507657

Last Updated: 2025-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-12
• Study Completion Date: 2029-01-15

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

empagliflozin

Intervention Type: DRUG

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 group

Group Type: PLACEBO_COMPARATOR

Placebo tablet

Intervention Type: DRUG

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.

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeremy Van't Hof, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Julie Dicken, RN

Role: CONTACT

dicke022@umn.edu

Facility Contacts

Julie Dicken

Role: primary

dicke022@umn.edu

Other Identifiers

CV-2023-32230

Identifier Type: -

Identifier Source: org_study_id