Blood PressurePhase 4NEURO-EMPANCT07799441
Neurovascular Effects of Empagliflozin
A Phase 4 study testing Empagliflozin (EMPA) in people with Blood Pressure and Endothelial Dysfunction, run by Kanokwan Bunsawat at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine whether empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, improves vascular and autonomic function in adults with prehypertension. The main questions this clinical trial aims to answer are: 1. Does empagliflozin improve endothelial function? 2. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Endothelial Dysfunction
- What is being tested?
- Empagliflozin (EMPA)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Jan 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Integrative Neurovascular Physiology Laboratory - University of Iowa
Iowa City, Iowa, 52242
Kanokwan Bunsawat, PHD, 3193351859, kanokwan-bunsawat@uiowa.edu
Nicholas Carlini, PHD, 484-947-7574, nicholas-carlini@uiowa.edu
About this study
Official title: Neurovascular Effects of Empagliflozin in Mid-Life and Older Adults With Prehypertension
The goal of this clinical trial is to examine whether empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, improves vascular and autonomic function in adults with prehypertension. The main questions this clinical trial aims to answer are:
- Does empagliflozin improve endothelial function?
- Does empagliflozin improve sympathetic nervous system function?
This clinical trial employs a double-blind, placebo-controlled crossover study lasting up to 6 weeks for participants with prehypertension and up to 2 weeks for normotensive participants. Participants with prehypertension will take empagliflozin or placebo for 2 weeks, separated by a 2-week washout. Normotensive participants will complete baseline, pre-treatment visits only and will serve as a control group.
Read the detailed description
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.
- Conditions
- Blood Pressure, Endothelial Dysfunction
- Being tested
- Empagliflozin (EMPA), Placebo
- Keywords
- Sodium-glucose cotransporter 2 inhibition, Prehypertension, Vascular Function
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empagliflozin (EMPA)Drug
Oral ingestion for 2 weeks
PlaceboOther
Oral placebo for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | Participants will receive Empagliflozin (25 mg once a day) for 2 weeks. Receives: Drug: Empagliflozin (EMPA); Other: Placebo |
| Placebo | Placebo comparator | Participants will receive placebo pills identical in appearance and taste. Receives: Drug: Empagliflozin (EMPA); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macrovascular endothelial function as assessed by brachial artery flow-mediated dilation (FMD)
The brachial artery will be imaged using high-resolution Doppler ultrasound at baseline and following a period of forearm blood-flow occlusion induced by an inflatable blood pressure cuff. FMD will be calculated as the percentage (%) increase in brachial artery diameter from baseline following cuff release, reflecting the ability of the brachial artery to dilate in response to increased blood flow and shear stress. Higher FMD values indicate greater endothelium-dependent vasodilatory function.
Measured: At the end of each 2-week treatment period
Secondary outcomes (1)
Sympathetic nervous system function as assessed by muscle sympathetic nerve activity
Muscle sympathetic nerve activity (MSNA) will be measured using microneurography, in which a recording electrode will be inserted into a nerve of the lower leg to directly record sympathetic nerve activity. Sympathetic bursts will quantified as burst frequency (bursts/min) and burst incidence (bursts/100 heartbeats). Higher values indicate greater MSNA sympathetic nerve activity.
Measured: At the end of each 2-week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-blind, placebo-controlled, crossover intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kanokwan Bunsawat
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kanokwan Bunsawat, University of Iowa
- Investigators
- Kanokwan Bunsawat, PHD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07799441
- Sponsor's protocol ID
- 202603388
- Acronym
- NEURO-EMPA
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurovascular Effects of Empagliflozin in Mid-Life and Older Adults With Prehypertension
- ClinicalTrials.gov ID
- NCT07799441
- Acronym / sponsor ID
- NEURO-EMPA / 202603388
- Conditions
- Blood Pressure, Endothelial Dysfunction
- Keywords
- Sodium-glucose cotransporter 2 inhibition, Prehypertension, Vascular Function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kanokwan BunsawatUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 2 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to examine whether empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, improves vascular and autonomic function in adults with prehypertension. The main questions this clinical trial aims to answer are:
- Does empagliflozin improve endothelial function?
- Does empagliflozin improve sympathetic nervous system function?
This clinical trial employs a double-blind, placebo-controlled crossover study lasting up to 6 weeks for participants with prehypertension and up to 2 weeks for normotensive participants. Participants with prehypertension will take empagliflozin or placebo for 2 weeks, separated by a 2-week washout. Normotensive participants will complete baseline, pre-treatment visits only and will serve as a control group.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, placebo-controlled, crossover intervention.
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin (EMPA), Other: PlaceboParticipants will receive Empagliflozin (25 mg once a day) for 2 weeks. |
| Placebo | Placebo comparator | Drug: Empagliflozin (EMPA), Other: PlaceboParticipants will receive placebo pills identical in appearance and taste. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Midlife and older (>/= 45-75 yrs) males and females
- Body mass index 18-35 kg/m2
- Able to give informed consent
- Normotensive (control group)
- Systolic (<120 mmHg) and Diastolic (<80 mmHg) Prehypertension (experimental group)
Key exclusion criteria (24 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empagliflozin (EMPA)Oral ingestion for 2 weeks | Drug | Empagliflozin, Placebo |
| PlaceboOral placebo for 2 weeks. | Other | Empagliflozin, Placebo |
Primary outcome
Macrovascular endothelial function as assessed by brachial artery flow-mediated dilation (FMD)
Time frame: At the end of each 2-week treatment period
The brachial artery will be imaged using high-resolution Doppler ultrasound at baseline and following a period of forearm blood-flow occlusion induced by an inflatable blood pressure cuff. FMD will be calculated as the percentage (%) increase in brachial artery diameter from baseline following cuff release, reflecting the ability of the brachial artery to dilate in response to increased blood flow and shear stress. Higher FMD values indicate greater endothelium-dependent vasodilatory function.
1 secondary outcome
Sympathetic nervous system function as assessed by muscle sympathetic nerve activity
Time frame: At the end of each 2-week treatment period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kanokwan Bunsawat, PHD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Empagliflozin (EMPA) in people with Blood Pressure and Endothelial Dysfunction, run by Kanokwan Bunsawat at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kanokwan Bunsawat, PHD (319-335-1859, kanokwan-bunsawat@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macrovascular endothelial function as assessed by brachial artery flow-mediated dilation (FMD) (time frame: At the end of each 2-week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.