Empagliflozin Reversal of Arterial StiffnEss in Aging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Empagliflozin 10 MG, Placebo.
- Who it may be relevant to
- Registry conditions: Aging, Arterial Stiffness. Basic parameters: 60 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SGLT2 Inhibition as a Therapeutic Strategy to Reverse Arterial Stiffening in Aging
Overview
Randomized placebo-controlled clinical trial in a cohort of males (n=40) and females (n=40), 60-80 years of age, with the hypothesis that SGLT2 inhibition with empagliflozin (10mg/day for 12 weeks) reduces aging-related arterial stiffening.
Detailed description
The investigators will employ a double-blinded randomized placebo control trial to determine the effects of 12 weeks of sodium glucose co-transporter 2 (SGLT2) inhibition with empagliflozin (10 mg daily), or matching placebo. Empagliflozin has been shown to decrease cardiovascular events and arterial stiffness in different populations. Placebo will be included for comparison purposes as empagliflozin is not a standard therapy for aging-associated arterial stiffness.
Interventions
- Drug Empagliflozin 10 MG
10mg Empagliflozin daily for 12 weeks - Drug Placebo
10mg Placebo daily for 12 weeks
Primary outcome measures
- Carotid Femoral Pulse Wave Velocity (cfPWV) [Time frame: Baseline (day 0), Week 4, Week 8, Final (week 12)]
Eligibility criteria
Inclusion criteria
- Able to provide consent
- 60 to 80 years of age at randomization (women must be postmenopausal defined as more than 1 year without menses)
- Stable anti-hypertensive medication regimen (if in use) for at least 90 days
- Evidence of arterial stiffening (defined as carotid-femoral PWV >/= 8 m/s) at the time of screening visit.
Exclusion criteria
- Diabetes
- BMI>/= 45kg/m2
- Known history of cardiovascular disease: heart failure, ischemic heart disease, peripheral artery disease or stroke
- Estimated glomerular filtration rate GFR < 29 mL/min
- Active cancer (excluding basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
- Excessive alcohol consumption (>14 drinks/week for men, >7 drinks/week for women)
- Use of hormone replacement therapy
- Body weight change ≥10% within the last 6 months
- Uncontrolled hypertension during screening visit (>180/110 mmHg)
- Symptomatic hypotension and/or a SBP <100 mmHg
- History of ketoacidosis
- High fall risk per assessment of study physician and/or safety officer at the time of screening (results must be abnormal for both fall risk assessments and orthostatic blood pressure measurements)
- Anticipated need of prolonged fasting
- History of recurrent UTIs or mycotic genital infections
- Following a low-carbohydrate diet (<20 grams/day)
- Participation in regular exercise > 3 days/week per week at a moderate or vigorous intensity
- Known sensitivity to nitrate medications
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Missouri — Columbia
Identifiers
NCT: NCT06506422 · 2097602