Overview
Prehypertension is recognized clinically as a precursor to hypertension, an independent predictor of cardiovascular disease (CVD) risk. Vascular and sympathetic nervous system dysfunction are non-traditional risk factors contributing to increased CVD risk that are mediated, in part, by systemic inflammation and oxidative stress. Targeting vascular and sympathetic nervous system function represents a therapeutic strategy for mitigating CVD risk in prehypertension.
Sodium-glucose cotransporter-2 (SGLT2) inhibitors (e.g., empagliflozin) have emerged as a transformative therapeutic class with robust anti-inflammatory and antioxidant properties. The efficacy of SGLT2 inhibitors to improve vascular and sympathetic nervous system function through reductions in pro-inflammatory and improved redox balance have yet to be investigated in prehypertension.
In this randomized, double-blind, placebo-controlled clinical trial, the investigators seek to utilize integrative methods for evaluating vascular and sympathetic nervous system function following 2-week treatment with empagliflozin. Understanding the mechanisms underpinning increased CVD risk in prehypertension will inform us about specific pharmacological prevention strategies in this ever-growing clinical population.
Principal investigator
Eligibility criteria
* Midlife and older (\>/= 45-75 yrs) males and females
* Body mass index 18-35 kg/m2
* Able to give informed consent Blood Pressure Status: Normotensive (control group)
* Systolic (\<120 mmHg) and Diastolic (\<80 mmHg) Prehypertension (experimental group)
* Systolic (120-129 mmHg) and Diastolic (\<80 mmHg) Exclusion Criteria
* Age \<45 and/or \>75 yrs
* BMI \>35 kg/m2
* Blood pressure: Systolic (\>130 mmHg) and Diastolic (\>80 mmHg)
* Anti-hypertensive therapy
* Type 2 diabetes (blood glucose \>126 mg/dL or HbA1c \>6.2%)
* Currently prescribed SGLT2i medication
* Currently prescribed GLP-1 medication
* Currently prescribed Beta-Blocker medication
* Known or recently (last 6 months) diagnosed renal, pulmonary, and/or neurological diseases/disorders (chronic kidney disease, acute kidney injury, kidney stones, urinary tract infection, glomerulonephritis, chronic obstructive pulmonary disease, asthma, pulmonary embolism, epilepsy, multiple sclerosis, Parkinson's, peripheral neuropathy)
* Known or recently (last 6 months) diagnosed cardiovascular and cerebrovascular disorders (heart failure, coronary artery disease, stroke, transient ischemic attack, cerebral aneurysm, arteriovenous malformation, cerebral venous thrombosis, dementia, Alzheimer's, moyamoya disease)
* Secondary or resistant hypertension (systolic blood pressure \>140 mmHg or diastolic blood pressure \>90 mmHg despite treatment with at least 3 different classes of antihypertensive medications
* History of cancer
* Smoking or tobacco/cannabis use (current use or quit within the last 6 months)
* Pregnant, breastfeeding, planning to become pregnant, or unwilling to use adequate birth control
* Psychiatric or psychological disorders
* Hormone-based therapy
* History of myocardial infarction, heart failure, liver disease, or chronic kidney disease (estimated glomerular filtration rate \< 60 ml/min/1.73m2)
* History of lactic acidosis
* History of alcohol abuse
* Severe infection within the last 30 days
* Immunosuppressive therapy within the past year
* Life expectancy \< 1 year
* Study compliance: Unwilling to fast overnight
* Known allergy to Empagliflozin
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