NCT06507657RecruitingEarly phase 1
Effect of Empagliflozin on Left Atrial Function in Adults at Risk for Heart Failure
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 11 Jul 2024
- Start date
- 12 Dec 2024
- Primary completion date
- 15 Jan 2029
- Lead sponsor
- University of Minnesota
- Diseases
- Heart failure, High blood pressure
- NCT number
- NCT06507657
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 80
- From 12 Dec 2024 to the primary completion date, 15 Jan 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
- 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.
Other illness
- Moderate or severe valve disease on echocardiogram
- History of genitourinary infection
- 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
- Unstable coronary syndromes
Lab values
- History of type 1 or type 2 diabetes mellitus by medical history or hemoglobin A1c \>7.0% at Visit 1
- Any LVEF measure of ≤40% on past echocardiogram
- eGFR \<60 ml/min/1.73 m2 at Visit 1
Other
- Female participants who are pregnant, lactating, or of child bearing potential
- Clinical diagnosis of HFpEF or HFrEF by participant self-report or documented in the electronic health record
- Inadequate quality echocardiographic images
- Non-English speaking individuals
Who the study is looking for
- 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
Age in the registry: 60 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.