Salt-Sensitivity and Immunity Cell Activation

NCT03753204 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: 182038
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Salt-sensitive hypertension affects nearly 50% of the hypertensive and 25% of the normotensive population, and strong evidence indicates that reducing salt intake decreases blood pressure and cardiovascular events. The precise mechanisms of how dietary salt contributes to blood pressure elevation, renal injury, and cardiovascular disease remains unclear. Our data indicated that monocytes exhibit salt sensitivity, and the investigators hypothesize that of salt sensitivity of these and similar immune cells correlate with the hypertensive response to salt intake. Currently, the research tools for diagnosing salt-sensitivity are costly, time consuming and laborious. In this study the investigators will identify monocyte salt-sensitivity as a marker of salt-sensitive hypertension.

Conditions

High Blood Pressure; Salt; Excess; Inflammation

Outcome Measures

Primary Outcomes (1)

• The percent of participants with salt sensitive blood pressure

  A reduction in systolic blood pressure \>9 mm Hg from the salt-loading to the salt-depletion periods will be used to classify a subject as salt sensitive

  Over 3 days

Secondary Outcomes (1)

• Percent of participants with immune cell activation

  Over 3 days

Study Arms (1)

Weinberger protocol

EXPERIMENTAL

During the Weinberger protocol, salt loading will be achieved by the combination of a high-salt diet (isocaloric, 160 mEq Na and 70 mEq K), and an infusion of 2L of saline (300 mEq Na+). Patients will have free access to water but their food will be limited to that provided by the protocol. Salt depletion will be accomplished by administering an isocaloric diet containing 10 mEq Na and 70 mEq K and continued unlimited water intake. At 8 am, 12 noon and 4 pm, subjects will be given 40 mg of furosemide or lasix orally.

Drug: Furosemide 40 mg

Interventions

Furosemide 40 mg DRUG

Blood pressure data from the monitors will be downloaded and the average of the systolic blood pressure of the day of salt loading, from 12 noon (end of the saline infusion) until 10 pm will be used as the BP for the salt-loading period of study. The average of the systolic blood pressure of the day of salt depletion, from 12 noon (second dose of furosemide) until 10 pm will be used as the BP for the salt-depleted period of study. A fall in systolic BP ≥10 mm Hg from the salt-loading to the salt-depletion periods will be used to classify a subject as salt sensitive.

Also known as: Lasix

Weinberger protocol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• We will perform a pilot analysis in 20 hypertensive subjects controlled for gender (50% men, 50% women), age (18-60 years),
• New or pre-existing diagnosis of essential hypertension defined as systolic blood pressure \>140 mmHg or \>90 mmHg diastolic or taking antihypertensive medications regardless of current blood pressure.
• BMI (18.5-24.9).
• Only subjects who give informed consent will be studied.

You may not qualify if:

• Acute cardiovascular event(s) within the previous 6 months
• Claustrophobia precluding obtaining an MRI
• Inability to understand the nature, scope, and possible consequences of the study or to participate in/comply with the protocol.
• Current excessive alcohol or illicit drug use.
• Presence of metal implants such as artificial joints.
• Concomitant diabetes mellitus, type I or II.
• Autoimmune disease.
• Recent vaccination
• Pregnancy.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (2)

• Weinberger MH, Miller JZ, Luft FC, Grim CE, Fineberg NS. Definitions and characteristics of sodium sensitivity and blood pressure resistance. Hypertension. 1986 Jun;8(6 Pt 2):II127-34. doi: 10.1161/01.hyp.8.6_pt_2.ii127.

  PMID: 3522418 BACKGROUND

• Weinberger MH, Fineberg NS. Sodium and volume sensitivity of blood pressure. Age and pressure change over time. Hypertension. 1991 Jul;18(1):67-71. doi: 10.1161/01.hyp.18.1.67.

  PMID: 1860713 BACKGROUND

MeSH Terms

Conditions

Hypertension; Inflammation

Interventions

Furosemide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfanilamides; Sulfonamides; Amides; Organic Chemicals; Aniline Compounds; Amines; Sulfones; Sulfur Compounds

Study Officials

• Annet Kirabo

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be given a high salt diet and 2 liters of saline (salt loading), followed by low salt diet and furosemide or lasix (salt depletion).

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 26, 2018
• Study Start: September 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-10

Locations

US (1)