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NCT Number: NCT06507657

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Julie Dicken

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. change in LA function

    Time frame: 9 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Dicken, RN

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Jul 18, 2024
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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