NCT06094816 Forebrain Electroneutral Transporters in Salt-sensitive Hypertension: an MRI Study
| NCT ID | NCT06094816 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Delaware |
| Condition | Salt-Sensitivity of Blood Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-03-05 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2024-03-05 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06094816 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 60 Years, studying Salt-Sensitivity of Blood Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06094816 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06094816 currently recruiting?
Yes, NCT06094816 is actively recruiting participants. Contact the research team at mwenner@udel.edu for enrollment information.
Where is the NCT06094816 trial being conducted?
This trial is being conducted at Newark, United States.
Who is sponsoring the NCT06094816 clinical trial?
NCT06094816 is sponsored by University of Delaware. The trial plans to enroll 120 participants.