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RecruitingNCT06507657Updated Oct 3, 2025

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

An Early Phase 1 interventional study of empagliflozin and Placebo tablet in Hypertension and Cardiovascular Diseases, sponsored by University of Minnesota. Recruiting at 1 site in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by University of Minnesota · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 9 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension
  • Cardiovascular Diseases
03

In context

Hypertension

6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.

This study's planned enrollment of 80 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.

Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Experimental group

    Drug: empagliflozin

  • Placebo comparator
    Placebo group

    Drug: Placebo tablet

Interventions

  • Drugempagliflozin

    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.

  • DrugPlacebo 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.

06

What researchers measure

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.

    Time frame: 9 months

Secondary outcomes

  1. change in left ventricular ejection fraction

    Time frame: 9 months

  2. change in global longitudinal strain

    Time frame: 9 months

  3. change in mass (indexed to body surface area)

    Time frame: 9 months

  4. change in E/e' ratio

    Time frame: 9 months

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

    Time frame: 9 months

  6. change in plasma protein levels: GDF15 (growth differentiating factor 15)

    Time frame: 9 months

  7. change in plasma protein levels: Spondin-1

    Time frame: 9 months

  8. change in plasma protein levels: IGBPF-7

    Time frame: 9 months

  9. change in plasma protein levels: THBS-2 (thrombospondin 2)

    Time frame: 9 months

  10. change in plasma protein levels: IGFBP-1 (insulin-like binding factor protein 1)

    Time frame: 9 months

  11. change in plasma protein levels: FABP-4 (fatty acid-binding protein 4)

    Time frame: 9 months

  12. change in plasma protein levels: CCL16 (C-C motif chemokine 16)

    Time frame: 9 months

  13. change in cardiovascular disease biomarker C-reactive protein (CRP)

    Time frame: 3 months and 9 months

  14. change in cardiovascular disease biomarker Troponin

    Time frame: 3 months and 9 months

  15. change in cardiovascular disease biomarker NT-proBNP

    Time frame: 3 months and 9 months

  16. changes in blood pressure ration

    Time frame: 1, 3 and 9 months

07

Study locations

1 of 1 sites recruiting
  • University of Minnesota
    Minneapolis, Minnesota 55414, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06507657
Lead sponsor
University of Minnesota
Responsible party
Sponsor
First posted
Jul 18, 2024
Start date
Dec 12, 2024
Primary completion
Jan 15, 2029 (estimated)
Completion
Jan 15, 2029 (estimated)
Last update
Oct 3, 2025

Study contacts

Julie Dicken, RN
Contact
dicke022@umn.edu
Jeremy Van't Hof, MD
principal investigator · University of Minnesota

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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