Impact of empagliflozin on heart function in older adults at risk for heart failure
Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
This study is testing if the diabetes medication empagliflozin can improve heart function in older adults at risk for heart failure.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06507657 on ClinicalTrials.gov |
What this trial studies
This pilot study investigates the effects of empagliflozin, a medication initially approved for type 2 diabetes, on left atrial function in adults over 60 years old who are at risk for heart failure. The study is designed as a placebo-controlled, double-blinded, randomized trial involving 80 participants, who will receive either empagliflozin or a placebo. The primary focus is to assess changes in heart function through echocardiograms conducted before and after treatment. The study aims to provide insights into the cardiovascular benefits of empagliflozin beyond its glucose-lowering effects.
Who should consider this trial
Good fit: Ideal candidates are adults over 60 years old with a clinical diagnosis of hypertension and a body mass index of 30 kg/m2 or higher.
Not a fit: Patients with a history of diabetes, heart failure, or significant kidney issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved heart function and reduced risk of heart failure in older adults with hypertension.
How similar studies have performed: Previous studies have shown that SGLT2 inhibitors can reduce cardiovascular events, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Jeremy Van't Hof, MD — University of Minnesota
- Study coordinator: Julie Dicken, RN
- Email: dicke022@umn.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.