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

University of Minnesota (UMN)

Status and phase

Enrolling

Early Phase 1

Conditions

Hypertension

Cardiovascular Diseases

Treatments

Drug: Placebo tablet

Drug: empagliflozin

Study type

Interventional

Funder types

Other

Identifiers

NCT06507657

CV-2023-32230

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

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