effect of empagliflozin on left atrial function in adults at risk for heart failure

Conditions: Hypertension; Cardiovascular Diseases

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.


Eligibility criteria:
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