Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
Recruiting · NCT06507657 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Minnesota
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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.
Who can take part
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
Where it is running
1 location listed across 1 US state.
- University of Minnesota - Minneapolis, Minnesota, United States