Effect of an Isolevuglandin Scavenger on Salt Sensitivity of Blood Pressure and Immune Cell Activation in Humans

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT07602166
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • High Blood Pressure
  • Inflammation
  • Renin-Angiotensin-Aldosterone System
  • Salt Sensitivity of Blood Pressure

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 2-hydroxybenzylamine — DRUG
    2HOBA
  • Placebo — DRUG
    Placebo

Study Details

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.

Key Dates

Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Drug-washout-placebo
    Participants with salt sensitivity of blood pressure to receive treatment with 2-HOBA (500mg) three times a day for 4 weeks, followed by a washout period of 4 weeks, and then placebo for 4 weeks
  • Experimental: Arm 2: Placebo-washout-Drug
    Participants with salt sensitivity of blood pressure to receive treatment with placebo for 4 weeks followed by a washout period of 4 weeks, and then 2-HOBA (500mg) three times a day for 4 weeks.

Primary Outcome Measure

Change in 24-hour ambulatory systolic blood pressure (SBP) [ Time Frame: From week 0-4 and week 8-week12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37232
Annet Kirabo, D.V.M., M.Sc., Ph.D. F.A.H.A.
[email protected]
615-343-0933
Talat A Ikizler, MD
[email protected]
Annet Kirabo, D.V.M., M.Sc., Ph.D. F.A.H.A. (PRINCIPAL_INVESTIGATOR)
Talat A Ikizler, MD (SUB_INVESTIGATOR)
David Harrison, MD (SUB_INVESTIGATOR)

Find similar trials in Nashville, TN

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Vanderbilt University Medical Center· Nashville, TN

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