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

NCT06507657 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: CV-2023-32230
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• change in LA function

  LA function will be quantified by assessing LA reservoir, conduit, and contractile strain with 2DE at baseline and 9 months.

  9 months

Secondary Outcomes (16)

• change in left ventricular ejection fraction

  9 months

• change in global longitudinal strain

  9 months

• change in mass (indexed to body surface area)

  9 months

• change in E/e' ratio

  9 months

• change in plasma protein levels: DLK-1 (protein delta homolog 1)

  9 months

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: empagliflozin

Placebo group

PLACEBO COMPARATOR

Drug: Placebo tablet

Interventions

empagliflozin 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.

Experimental group

Placebo tablet 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.

Placebo group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Hypertension; Cardiovascular Diseases

Interventions

empagliflozin

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Jeremy Van't Hof, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Dicken, RN

CONTACT

dicke022@umn.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: placebo-controlled, double-blinded, randomized pilot study

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 18, 2024
• Study Start: December 12, 2024
• Primary Completion (Estimated): January 15, 2029
• Study Completion (Estimated): January 15, 2029
• Last Updated: October 3, 2025

Record last verified: 2025-10

Locations

US (1)