IsoLG scavenger 2-HOBA for salt sensitivity of blood pressure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II, randomized, double-blind, placebo-controlled 2x2 crossover trial evaluating 2-HOBA in adults with salt-sensitive blood pressure. Participants will first receive 2-HOBA or placebo for four weeks, undergo a four-week washout, and then swap treatments for another four weeks, with safety monitoring and multiple assessments over 12 weeks. The study uses the Weinberger protocol to phenotype salt sensitivity and includes 24-hour urine collection and in-hospital monitoring to track blood pressure and biomarkers. Primary aims are to see if 2-HOBA can blunt endothelial dysfunction linked to IsoLGs and reduce salt-induced blood pressure changes. The trial is sponsored by Vanderbilt University Medical Center with NIH collaboration.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Annet Kirabo, D.V.M., M.Sc., Ph.D. F.A.H.A.
• Email: annet.kirabo@vumc.org
• Phone: 615-343-0933

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.