Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
University of Minnesota · Other
Who this trial is looking for
This trial is looking for adults over 60 years old who have high blood pressure and a higher body weight. Participants will take either a daily tablet of empagliflozin or a placebo to see how it affects heart function.
Are You a Good Fit for This Trial?
Rules you outUnstable coronary syndromesAny major surgery in the past 90 days
You may be able to join if
I am over 60 years old.
I have been diagnosed with high blood pressure.
I have a body mass index of 30 or higher.
I have had an echocardiogram within the last 60 days.
You may not be able to join if
I am pregnant, breastfeeding, or could become pregnant.
I have a history of type 1 or type 2 diabetes.
I have been diagnosed with heart failure.
My heart's left ventricular ejection fraction is 40% or lower.
I have had moderate or severe valve disease.
I have a history of urinary infections.
My kidney function is below a certain level.
I am currently on certain heart medications.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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.
Trial Locations
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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 pote…
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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