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

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Salt Sensitivity of Blood Pressure, High Blood Pressure, Inflammation, Renin-Angiotensin-Aldosterone System

In brief

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 facts

Study ID

NCT07602166

Run by

Vanderbilt University Medical Center

People needed

20

Starts

2026-09-01

Expected to finish

2031-07-01

Last updated by the study team

2026-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• We will perform analyses in participants previously phenotyped for SSBP, defined as a change in systolic blood pressure ≥10 mmHg from salt-loading to salt-depletion,
• Over 18 years of age. Able to give informed consent,

You may not qualify if…

• Salt-resistant people,
• Acute cardiovascular event(s) within the previous 6 months,
• 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,
• BP below the inclusion criteria levels after discontinuation of therapy,
• Concomitant diabetes mellitus, type I or II,
• Autoimmune disease,
• Recent vaccination,
• Younger or older than inclusion criteria,
• Pregnant or breastfeeding
• Women of childbearing potential unwilling to use highly effective contraceptive (see Risk section),
• Confirmed or suspected renal, renovascular or endocrine causes of secondary hypertension,
• Treatment with agents known to increase BP (e.g., adrenergic agonists for ADHD, SSRI and SNRI antidepressants, chronic use of decongestants or non-steroidal anti-inflammatory drugs,
• Active or ongoing infection, including HIV/AIDS,
• Active or ongoing malignancy with the exception of basal cell carcinoma of the skin,
• Severe psychiatric disorders,
• Any condition that may alter the immunological results of the study including rheumatoid arthritis, systemic lupus erythematosus, dermatomyositis, giant cell arteritis, psoriasis, inflammatory bowel disease, and multiple sclerosis,
• Use of glucocorticoids, immunosuppressants, direct immunomodulators or chemotherapeutic drugs that in the judgment of the investigators may include a major inflammatory component,
• Individuals who have contraindications to high salt diets (e.g. heart, renal, or liver failure) or low salt diets (e.g. postural orthostatic tachycardia syndrome, prescribed salt tablets, fludrocortisone or midodrine) or 24-hr ambulatory blood pressure monitoring (e.g. women with bilateral upper extremity lymphedema following breast cancer surgeries),
• Prior diagnosis of liver cirrhosis or the following abnormal liver function studies: AST or ALT >1.5x the upper limit of normal or total bilirubin ≥1.5 mg/dl,
• Use of Aspirin,
• Use of monoamine oxidase inhibitors (MAO-I),
• Individuals with medical contraindications to certain food content,
• Use of nitrate therapy. (Participants who are taking PDE-5 inhibitors will be instructed to discontinue use at least 48 hours prior to testing),
• Patients with resistant hypertension, defined as above-goal blood pressure despite the concurrent use of three antihypertensive drug classes at screening, will be excluded for safety reasons,

Where it is running

• Vanderbilt University Medical Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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