Empagliflozin Reversal of Arterial StiffnEss in Aging
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age60-80
SponsorUniversity of Missouri-Columbia
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Empagliflozin 10 MG
Drug10mg Empagliflozin daily for 12 weeks
Placebo
Drug10mg Placebo daily for 12 weeks
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: EmpagliflozinExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Carotid Femoral Pulse Wave Velocity (cfPWV)
cfPWV is the gold standard non-invasive index of arterial stiffness. Transit time between carotid and femoral pressure waves is calculated using the foot-to-foot method. cfPWV is calculated as distance traveled by the pulse wave (i.e., femoral location-sternal notch minus sternal notch-carotid location) divided by pulse transit time. All the measurements will be done by the same blinded technician. The goal is to assess changes from baseline when compared to weeks 4,8, and 12 time points. Report
Time frame
Baseline (day 0), Week 4, Week 8, Final (week 12)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov