2-HOBA for Salt Sensitivity of Blood Pressure

AK
CM
Overseen ByCindy Mambungu, LPN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called 2-HOBA (2-hydroxybenzylamine) to determine its effectiveness for individuals with salt-sensitive high blood pressure. Salt sensitivity causes significant blood pressure increases with high salt intake, raising heart problem risks. The study aims to assess whether 2-HOBA can improve blood vessel and immune cell function in these individuals. Those who experience significant blood pressure changes with salt intake and have had high blood pressure for some time may be suitable candidates for this trial. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop taking my current medications for the trial?

Yes, you may need to stop taking certain medications. The trial excludes participants using specific drugs like aspirin, MAO inhibitors, and others that could interact with the study treatment. It's best to discuss your current medications with the trial team to see if any need to be stopped.

Is there any evidence suggesting that 2-hydroxybenzylamine is likely to be safe for humans?

Research has shown that 2-hydroxybenzylamine (2-HOBA) is generally safe and well-tolerated. In earlier studies, healthy volunteers took doses up to 825 mg without significant problems. Another study found that taking 750 mg three times a day for 15 days was also safe. These findings suggest that 2-HOBA can be used at these doses without major safety concerns. Although the FDA has not approved 2-HOBA for any specific condition, its safety in these studies supports its potential use in clinical trials for conditions like salt sensitivity of blood pressure.12345

Why do researchers think this study treatment might be promising?

Most treatments for salt sensitivity of blood pressure focus on reducing salt intake or using medications like diuretics and ACE inhibitors to manage blood pressure. However, 2-hydroxybenzylamine (2-HOBA) is unique because it targets oxidative stress, which is a different approach from the standard methods. Unlike other treatments that primarily address the symptoms or causes of high blood pressure, 2-HOBA works by neutralizing reactive molecules that contribute to oxidative stress, potentially preventing blood pressure spikes caused by salt intake. Researchers are excited about 2-HOBA because it offers a novel way to manage salt sensitivity that could complement or enhance existing treatments.

What evidence suggests that 2-HOBA might be an effective treatment for salt sensitivity of blood pressure?

Studies have shown that many people with high blood pressure are sensitive to salt, increasing their risk of heart problems. Research suggests that a compound called 2-hydroxybenzylamine (2-HOBA) might help by targeting harmful molecules known as isolevuglandins (IsoLGs), which contribute to this issue. Early evidence indicates that 2-HOBA can improve blood vessel function and boost immune cell activity. This trial will evaluate 2-HOBA's potential to reduce the impact of salt on blood pressure and lower related heart risks. Initial findings suggest it could be a promising option for managing blood pressure problems linked to salt intake. Participants in this trial will join different arms to assess the effects of 2-HOBA compared to a placebo.23678

Are You a Good Fit for This Trial?

This trial is for adults with high blood pressure, especially those whose blood pressure increases with salt intake. Participants should not have other major health issues that could interfere with the study.

Inclusion Criteria

Participants previously phenotyped for SSBP, defined as a change in systolic blood pressure ≥10 mmHg from salt-loading to salt-depletion
Able to give informed consent
I am over 18 years old.

Exclusion Criteria

Current excessive alcohol or illicit drug use
I have an autoimmune disease.
My age does not meet the study's requirements.
See 24 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants receive 2-HOBA or placebo for 4 weeks, followed by a 4-week washout, then crossover to the alternate treatment for another 4 weeks

12 weeks
4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • 2-hydroxybenzylamine

Trial Overview

The study tests whether a drug called 2-hydroxybenzylamine (2-HOBA) can reduce how much salt affects blood pressure and immune cell activity in people with hypertension, compared to a placebo. It is a randomized phase 2 trial.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Arm 2: Placebo-washout-DrugExperimental Treatment2 Interventions
Group II: Arm 1: Drug-washout-placeboExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

Citations

Effect of an Isolevuglandin Scavenger on Salt Sensitivity ...

The study will explore the impact of immunity on salt sensitivity and assess 2-HOBA's potential to reduce endothelial dysfunction, improve ...

Pathophysiology and genetics of salt-sensitive hypertension

Salt-sensitivity affects nearly 50% of the hypertensive and 25% of the normotensive individuals (Weinberger et al., 1986; He et al., 2013; Elijovich et al., ...

DC ENaC-Dependent Inflammasome Activation ...

Salt sensitivity of blood pressure puts both normotensive and hypertensive individuals at a higher risk for cardiovascular morbidity and mortality. •. The ...

Salt sensitivity may increase risk of high blood pressure

Salt-sensitive people may have an increased risk of high blood pressure, according to research that points to the need for better genetic ...

Dietary salt and blood pressure: A complex connection

60% of people with high blood pressure are salt sensitive, meaning they have a strong response to dietary sodium. Their blood pressure rises by 5 points or ...

First-in-human study assessing safety, tolerability, and ... - PMC

Conclusions. 2-HOBA acetate was safe and well-tolerated at doses up to 825 mg in healthy human volunteers, positioning it as a good candidate ...

A Revolutionary Approach to Cellular Health with 2-HOBA

Treatment with 2-HOBA normalized blood pressure and prevented vascular inflammation, further establishing the connection between oxidative ...

2-HOBA for Rheumatoid Arthritis · Info for Participants

Research has shown that 2-HOBA is generally safe and well-tolerated. In animal studies, it reduced inflammation and other health issues without causing major ...