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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hypertension
Intervention / Treatment

-

Contacts and Locations

Minneapolis

University of Minnesota, Minneapolis, Minnesota, United States, 55414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Minnesota,

Jeremy Van't Hof, MD, PRINCIPAL_INVESTIGATOR, University of Minnesota

Study Record Dates

2029-01-15