Salt Sensitivity of Blood Pressure study: 2-hydroxybenzylamine
Official title Effect of an Isolevuglandin Scavenger on Salt Sensitivity of Blood Pressure and Immune Cell Activation in Humans
ClinicalTrials.gov ID: NCT07602166
What this study is testing
What is 2-hydroxybenzylamine?
2-hydroxybenzylamine is an investigational medicine, being studied as a potential treatment for salt sensitivity of blood pressure.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- Over 18 years of age. Able to give informed consent,
You likely can't join 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,
See the full eligibility 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,
- 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Nashville, Tennessee, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.