Can a diabetes drug shield the heart before failure strikes?
NCT ID NCT06507657
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase study tests whether empagliflozin, a drug originally for diabetes, can improve left atrial function in 80 adults over 60 with hypertension and obesity who are at risk for heart failure. Participants take either a 10 mg empagliflozin tablet or a placebo daily for 9 months. The goal is to see if the drug helps the heart's upper chambers work better, potentially preventing future heart failure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- empagliflozin
- What this could lead to
- If it works, this could point toward a way to prevent heart failure in people with high blood pressure and obesity.
- What could go wrong
- This is a very early, small pilot study with only 80 participants. It may not show clear benefits, and empagliflozin can cause side effects like dehydration or urinary infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2024
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Minnesota
RECRUITINGMinneapolis, Minnesota, 55414, United States
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