Salt-Sensitivity of Blood PressurePhase 4NCT06094816
Forebrain Electroneutral Transporters in Salt-sensitive Hypertension: an MRI Study
A Phase 4 study testing Furosemide (Diuretic) and Hypertonic Saline Infusion in people with Salt-Sensitivity of Blood Pressure, run by University of Delaware at 1 site in United States.
Trial summary
The overall objective of this project is to identify the key salt-sensing regions of the brain and determine the underlying mechanism of sodium sensing. The investigators will assess how the brain responds to an acute increase of salt in the blood using MRI. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Salt-Sensitivity of Blood Pressure
- What is being tested?
- Furosemide (Diuretic) and Hypertonic Saline Infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2024to 1 Jul 2028
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age: > 40 years or < 60 years
- Blood pressure: > 100/60 mmHg or < 140/90 mmHg
- BMI: > 18.5 kg/m2 or < 35 kg/m2
- Serum potassium: > 3.5 mmol/L or < 5.5 mmol/L
- No history of cardiovascular, renal, metabolic, or neurological disease
Who cannot join
- Age: < 40 years or > 60 years
- Blood pressure: < 100/60 mmHg or > 140/90 mmHg
- BMI: < 18.5 kg/m2 or > 30 kg/m2
- Serum potassium: < 3.5 mmol/L or > 5.5 mmol/L
- Abnormal ECG
- History of - cardiovascular, cancer, metabolic, respiratory, renal disease
Show all 17Show fewer
- Hormone replacement therapy
- Current tobacco or nicotine use
- Pregnant or nursing mothers
- Major brain injury (concussions do not count)
- Clinically diagnosed psychiatric or neurological disorder
- Clinically diagnosed anxiety or depression
- Psychiatric, neurological, anxiety or depression medications
- Hypertension medications
- Sulfonamide drug allergy
- Contra-indications to MRI (implants, metal, etc)
- Claustrophobia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Virginia Nuckols, PhD contact
United States1 site, 1 recruiting
- Recruiting
University of Delaware
Newark, Delaware, 19713
Ginny Nuckols, PhD, gnuckols@udel.edu
Katherine Masso, BS, kcmasso@udel.edu
About this study
The overall objective of this project is to identify the key salt-sensing regions of the brain and determine the underlying mechanism of sodium sensing. The investigators will assess how the brain responds to an acute increase of salt in the blood using MRI. This will be done during a 30-minute infusion of a saline solution containing 3% salt. One trial will be conducted with a salt sensing channel blocker and one trial without the salt sensing channel blocker. This will help to assess the role of a specific salt sensing channel in the brain. Salt sensitivity of BP will be assessed using 7-day dietary feeding where participants will be given food to consume for 7-days. Comparisons will be made between salt resistant (no change in blood pressure going from low to high salt diets) and salt sensitive adults (a change in blood pressure going from low to high salt diets). The investigators think the changes in MRI will be greater in salt sensitive compared to salt resistant subjects.
Read the detailed description
The ability of the brain to sense changing sodium levels in the blood is critical in mediating the neurohumoral responses to hypernatremia, however, the mechanisms underlying sodium sensing in humans is poorly understood. The purpose of this study is to identify key sodium-sensing regions of the human brain in middle-aged men and women with high blood pressure and determine if the Na-K-2Cl co-transporter (NKCC2) mediates the neurohumoral response to acute hypernatremia. The investigators plan on comparing these central sodium responses to acute hypernatremia between salt-sensitive and salt-resistant adults. In this randomized double-blinded crossover study subjects will have a 3% NaCl (hypertonic saline) infusion with or without NKCC2 antagonism (furosemide). Completion of this project will increase the understanding of blood pressure regulation, which has major public health implications.
- Conditions
- Salt-Sensitivity of Blood Pressure
- Being tested
- Furosemide (Diuretic), Hypertonic Saline Infusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furosemide (Diuretic)Drug
Also called Lasix
The diuretic furosemide will be given during a 3% hypertonic saline infusion to examine blockade of the NKCC2.
Hypertonic Saline InfusionOther
3% Hypertonic saline infusion to acutely increase sodium and osmolality
| Study group | Role | What they receive |
|---|---|---|
| Salt Resistant Adults | Experimental | Adults who experience minimal BP change during dietary sodium challenge Receives: Drug: Furosemide (Diuretic); Other: Hypertonic Saline Infusion |
| Salt Sensitive | Experimental | Adults who experience increased BP (mean arterial pressures >5mmHg) during dietary sodium challenge Receives: Drug: Furosemide (Diuretic); Other: Hypertonic Saline Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bold fMRI
Intensity of sodium sensing regions of the brain
Measured: 1 hour
Secondary outcomes (1)
Blood Pressure
Systolic and Diastolic Blood pressure responses to hypertonic saline
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start5 Mar 2024
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salt-Sensitivity of 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blind randomized cross-over
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094816
- Sponsor's protocol ID
- 2053776
- Other IDs
- R01HL163906
- Status last verified
- Mar 2026
- First submitted
- 11 Oct 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forebrain Electroneutral Transporters in Salt-sensitive Hypertension: an MRI Study
- ClinicalTrials.gov ID
- NCT06094816
- Acronym / sponsor ID
- 2053776
- Conditions
- Salt-Sensitivity of Blood Pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 23 Oct 2023 (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 overall objective of this project is to identify the key salt-sensing regions of the brain and determine the underlying mechanism of sodium sensing. The investigators will assess how the brain responds to an acute increase of salt in the blood using MRI. This will be done during a 30-minute infusion of a saline solution containing 3% salt. One trial will be conducted with a salt sensing channel blocker and one trial without the salt sensing channel blocker. This will help to assess the role of a specific salt sensing channel in the brain. Salt sensitivity of BP will be assessed using 7-day dietary feeding where participants will be given food to consume for 7-days. Comparisons will be made between salt resistant (no change in blood pressure going from low to high salt diets) and salt sensitive adults (a change in blood pressure going from low to high salt diets). The investigators think the changes in MRI will be greater in salt sensitive compared to salt resistant subjects.
Detailed description
The ability of the brain to sense changing sodium levels in the blood is critical in mediating the neurohumoral responses to hypernatremia, however, the mechanisms underlying sodium sensing in humans is poorly understood. The purpose of this study is to identify key sodium-sensing regions of the human brain in middle-aged men and women with high blood pressure and determine if the Na-K-2Cl co-transporter (NKCC2) mediates the neurohumoral response to acute hypernatremia. The investigators plan on comparing these central sodium responses to acute hypernatremia between salt-sensitive and salt-resistant adults. In this randomized double-blinded crossover study subjects will have a 3% NaCl (hypertonic saline) infusion with or without NKCC2 antagonism (furosemide). Completion of this project will increase the understanding of blood pressure regulation, which has major public health implications.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind randomized cross-over
| Arm | Type | Receives |
|---|---|---|
| Salt Resistant Adults | Experimental | Drug: Furosemide (Diuretic), Other: Hypertonic Saline InfusionAdults who experience minimal BP change during dietary sodium challenge |
| Salt Sensitive | Experimental | Drug: Furosemide (Diuretic), Other: Hypertonic Saline InfusionAdults who experience increased BP (mean arterial pressures >5mmHg) during dietary sodium challenge |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: > 40 years or < 60 years
- Blood pressure: > 100/60 mmHg or < 140/90 mmHg
- BMI: > 18.5 kg/m2 or < 35 kg/m2
- Serum potassium: > 3.5 mmol/L or < 5.5 mmol/L
- No history of cardiovascular, renal, metabolic, or neurological disease
Key exclusion criteria (17 listed)
- Age: < 40 years or > 60 years
- Blood pressure: < 100/60 mmHg or > 140/90 mmHg
- BMI: < 18.5 kg/m2 or > 30 kg/m2
- Serum potassium: < 3.5 mmol/L or > 5.5 mmol/L
- Abnormal ECG
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 |
|---|---|---|
| Furosemide (Diuretic)Also: LasixThe diuretic furosemide will be given during a 3% hypertonic saline infusion to examine blockade of the NKCC2. | Drug | Salt Resistant Adults, Salt Sensitive |
| Hypertonic Saline Infusion3% Hypertonic saline infusion to acutely increase sodium and osmolality | Other | Salt Resistant Adults, Salt Sensitive |
Primary outcome
Bold fMRI
Time frame: 1 hour
Intensity of sodium sensing regions of the brain
1 secondary outcome
Blood Pressure
Time frame: 1 hour
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 24 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Virginia Nuckols, PhD contact
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 Furosemide (Diuretic) and Hypertonic Saline Infusion in people with Salt-Sensitivity of Blood Pressure, run by University of Delaware 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 5 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 24 Mar 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. 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 Megan Wenner, PhD (3028317343, mwenner@udel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bold fMRI (time frame: 1 hour). 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 24 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.