2-HOBA for Lupus: A 2-period crossover study to see if scavenging IsoLGs lowers 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 randomized, double-blind, placebo-controlled, crossover phase II trial in adults with SLE. Participants will receive 2-HOBA acetate or placebo for 8 weeks, followed by a 4-week washout, then 8 weeks of the alternate treatment. Primary outcomes include changes in 24-hour blood pressure and NETosis as a marker of immune activation. The study aims to understand whether scavenging IsoLGs, products of oxidative stress, can mitigate hypertension and immune-driven inflammation in SLE. The trial is sponsored by Vanderbilt University Medical Center with NHLBI collaboration and is conducted at VUMC in Nashville.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Written informed consent
* Age ≥18 years
* Female (biological)
* Meeting the 2019 European League Against Rheumatism/ American College of Rheumatology classification criteria for SLE32
* No change in immunosuppressants ≥3 months
* Stable prednisone (or equivalent) dose ≤ 20mg/ day for ≥ 1 month
* Elevated blood pressure defined as \>120 and \< or = 160 mmHg systolic or \>80 and \< or = 110 mmHg diastolic blood pressure at screening visit
* No change in anti-hypertensive dose ≥2 weeks
* Willingness to stop NSAIDs for ≥2 weeks before and throughout the study
* If of childbearing potential, willingness to use effective birth control throughout the study and 4 weeks after completion of the study (examples: condom, diaphragm, oral contraceptive pill, intrauterine device)

Exclusion Criteria:

* Pregnant or breastfeeding
* Male (biological)
* Active cancer except for non-melanoma skin cancer
* 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
* Active infection requiring medical intervention
* Major surgery in ≤ 3 months
* Aspirin allergy
* Use of MAO-I
* Estimated creatinine clearance \<30 ml/min
* Known atrial fibrillation
* Severe comorbid condition

Where it's running

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

Study contacts

• Principal investigator: Michelle J Ormseth, MD, MSCI — Vanderbilt University Medical Center
• Study coordinator: Phicharmon Kulapatana (study coordinator)
• Email: phicharmon.kulapatana@vumc.org
• Phone: 615-936-5747

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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.