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

NCT06094816 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 2053776R01HL163906
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Salt-Sensitivity of Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Bold fMRI

  Intensity of sodium sensing regions of the brain

  1 hour

Secondary Outcomes (1)

• Blood Pressure

  1 hour

Other Outcomes (1)

• Sympathetic Nerve Activity

  1 hour

Study Arms (2)

Salt Resistant Adults

EXPERIMENTAL

Adults who experience minimal BP change during dietary sodium challenge

Drug: Furosemide (Diuretic); Other: Hypertonic Saline Infusion

Salt Sensitive

EXPERIMENTAL

Adults who experience increased BP (mean arterial pressures \>5mmHg) during dietary sodium challenge

Drug: Furosemide (Diuretic); Other: Hypertonic Saline Infusion

Interventions

Furosemide (Diuretic) DRUG

The diuretic furosemide will be given during a 3% hypertonic saline infusion to examine blockade of the NKCC2.

Also known as: Lasix

Salt Resistant Adults; Salt Sensitive

Hypertonic Saline Infusion OTHER

3% Hypertonic saline infusion to acutely increase sodium and osmolality

Salt Resistant Adults; Salt Sensitive

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Delaware: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

University of Delaware

Newark, Delaware, 19713, United States

RECRUITING

MeSH Terms

Interventions

Furosemide; Diuretics

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds; Natriuretic Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Megan Wenner, PhD

CONTACT

3028317343; mwenner@udel.edu

Virginia Nuckols, PhD

CONTACT

gnuckols@udel.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind randomized cross-over

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: October 23, 2023
• Study Start: March 5, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)