2-HOBA for Salt Sensitivity of Blood Pressure

Overseen By Cindy Mambungu, LPN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Vanderbilt University Medical Center

Must not be taking: Antidepressants, Antipsychotics, Glucocorticoids, Immunosuppressants

Disqualifiers: Diabetes, Autoimmune disease, Recent vaccination, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

Hypertension is the leading cause of preventable deaths globally, driven by complications such as myocardial infarction, stroke, heart failure, and kidney disease. Recent updates in hypertension classification by the American Heart Association (AHA) place nearly half of the U.S. population in the hypertensive category. Excess dietary salt is a major risk factor for hypertension, with 50% of hypertensive individuals exhibiting salt-sensitivity of blood pressure (SSBP). SSBP is an independent predictor of cardiovascular events and death. While kidney mechanisms in salt-sensing have been extensively studied, emerging evidence suggests that immune cells can also sense sodium (Na+).

This trial hypothesizes that myeloid cell-derived isolevuglandins (IsoLGs) drive endothelial dysfunction, perpetuating the salt-sensitive phenotype. Preliminary data indicate that targeting IsoLGs with the IsoLG scavenger 2-hydroxybenzylamine (2-HOBA) may interrupt this immune-vascular axis, reducing salt sensitivity and associated cardiovascular risks.

This phase 2 clinical trial aims to investigate the role of 2-HOBA in modulating immune cell function within blood vessels in hypertensive patients. The study will explore the impact of immunity on salt sensitivity and assess 2-HOBA's potential to reduce endothelial dysfunction, improve immune cell activation, and alleviate SSBP.

Are You a Good Fit for This Trial?

This trial is for adults with high blood pressure, especially those whose blood pressure increases with salt intake. Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

Participants previously phenotyped for SSBP, defined as a change in systolic blood pressure ≥10 mmHg from salt-loading to salt-depletion

Able to give informed consent

I am over 18 years old.

Exclusion Criteria

Current excessive alcohol or illicit drug use

I have an autoimmune disease.

My age does not meet the study's requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive 2-HOBA or placebo for 4 weeks, followed by a 4-week washout, then crossover to the alternate treatment for another 4 weeks

12 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 2-hydroxybenzylamine

Trial Overview

The study tests whether a drug called 2-hydroxybenzylamine (2-HOBA) can reduce how much salt affects blood pressure and immune cell activity in people with hypertension, compared to a placebo. It is a randomized phase 2 trial.

How Is the Trial Designed?

Group I: Arm 2: Placebo-washout-Drug Experimental Treatment 2 Interventions

Participants with salt sensitivity of blood pressure

Group II: Arm 1: Drug-washout-placebo Experimental Treatment 2 Interventions

Participants with salt sensitivity of blood pressure

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials

922

Recruited

939,000+