RecruitingPhase 4

Forebrain Electroneutral Transporters in Salt-sensitive Hypertension: an MRI Study

United States120 participantsStarted 2024-03-05

Plain-language 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. 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.

Who can participate

Age range

40 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Bold fMRI

Timeframe: 1 hour

Trial details

NCT IDNCT06094816

SponsorUniversity of Delaware

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

Contact for this trial

Megan Wenner, PhD

3028317343 mwenner@udel.edu

View on ClinicalTrials.gov More Salt-Sensitivity of Blood Pressure trials