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Not yet recruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Infusions, Blood draws, Heart tracing (ECG), Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Investigators will randomize people with known SSBP (i.e., 10 mmHg drop in systolic blood pressure from salt-loading to salt-depletion) to 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 versus placebo then washout then 2-HOBA."
  • "Salt loading will be achieved by the combination of a high-salt diet (isocaloric, with 160 mEq Na and 70 mEq K), which the patient will consume in its entirety, and an infusion of 2L of saline (300 mEq Na+)."
  • "On the following morning (6 am) body weight and blood samples will again be obtained, and the 24-hr collection will be completed with an intentional voiding at 8 am."
  • "The next morning (6 am) the last recording of body weight and drawing of blood samples will take place, and by 8 am the 12-hour urine collection for the period of salt depletion will be completed."
  • "Laboratory blood measurements: Tests to be conducted in the 3 daily sets of blood samples will include CBCs and CMP at the central laboratory of VUMC."
  • "Definition of salt sensitivity of blood pressure: 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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests 2-HOBA in adults with high blood pressure that changes with salt intake. Researchers want to learn if it can reduce salt's effect on blood pressure, change immune cell activity, and help blood vessels work better.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Older than 18 and able to understand and agree to join the study.
  • Previously tested for salt-sensitive blood pressure: the top blood pressure number changed by at least 10 mmHg between high-salt and low-salt conditions.

Who can't join

  • Blood pressure that does not respond to salt; blood pressure too low after stopping treatment; an average office reading above 160 for the top number or 100 for the bottom number; or blood pressure above goal despite three types of blood pressure medicine.
  • A heart or blood vessel event in the past 6 months; diabetes; or high blood pressure caused or possibly caused by kidney, kidney blood vessel, or hormone problems.
  • An autoimmune disease, where the immune system attacks the body; another condition that could change immune test results; a recent vaccine; an ongoing infection, including HIV/AIDS; or active cancer other than basal cell skin cancer.
  • Pregnant, breastfeeding, or able to become pregnant but unwilling to use highly effective birth control.
  • Unable to understand or follow the study; a severe mental health disorder; or current excessive alcohol or illegal drug use.
  • A condition that makes high-salt or low-salt diets, certain foods, or 24-hour blood pressure monitoring unsafe; liver scarring called cirrhosis; or liver blood tests above the study's limits.
  • Use of aspirin, MAO-I antidepressants, nitrate medicines, medicines that raise blood pressure, or certain steroids, immune-system medicines, or cancer medicines.
  • Use of medicines that could interact with the study drug, including certain blood thinners, beta-blockers, heart rhythm medicines, antidepressants, and antipsychotics. People taking PDE-5 inhibitors must stop them at least 48 hours before testing.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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, Exclusion criteria: * 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, * Average of three office-based blood pressure readings greater than 160 mmHg systolic or 100 mmHg diastolic will not be eligible for enrollment, * Use of drugs such as anticoagulants (e.g., warfarin), beta-blockers, antiarrhythmics, antidepressants/antipsychotics, and other medications primarily metabolized by CYP2C9, CYP2C19, and CYP2D6 that may cause drug-drug interaction.

Study sites (1)

TN