NCT06246396

Antihypertensive Mechanisms of Minocycline in Resistant Hypertension

Antihypertensive Mechanisms of Minocycline in Resistant Hypertension: Role of the Gut Microbiota-brain-immune Axis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the mechanisms by which minocycline effect blood pressure in individuals with treatment-resistant hypertension. The main questions it aims to answer are: * To what extent does minocycline lower blood pressure? * Are such blood pressure effects mediated through changes in gut microbiota, gut leakiness, systemic inflammation, neuroinflammation, or some combination of these? Participants will be randomly assigned to treatment with minocycline or placebo, treated daily for 3 months, to evaluate these questions.

Detailed description

One hundred twenty patients with treatment-resistant hypertension will be enrolled. A total of 34 patients (17 from each treatment arm), who are participants in the main study, will also be enrolled in a substudy that includes neuroimaging. The study will last 3 months, and will include 3 visit time points (screening, randomization visit, 3-month follow-up visit). Participants will be randomly assigned, in a 1:1 allocation, to minocycline 100 mg twice per day, or matching placebo, each provided by the study, and investigators will be blinded to treatment assignment. At the baseline and 3-month follow-up visit, subjects will undergo: * A comprehensive medical history and examination, including assessment of antihypertensive treatment history * A series of behavioral activity questionnaires * Blood tests (plasma renin activity, aldosterone, catecholamines, serum creatinine, lipid panel, hemoglobin a1c, as well as various biomarkers of immune and inflammatory activity, and gut leakiness markers) * Urine/saliva tests for antihypertensive adherence * Gut microbiota profiling via whole metagenomic sequencing of stool samples * Blood pressure (BP) measurement, including unattended office BP and 24-hour ambulatory BP Subjects enrolled in the neuroimaging substudy will also have PET/MR imaging performed at each visit. Neuroimaging activities will take place at Emory University in Atlanta, GA. At the final visit (3-month follow-up), participants will also have blood tests to measure study drug concentration, as a measure of adherence to the assigned treatment.

Conditions

• Hypertension, Resistant to Conventional Therapy

Interventions

Type	Name	Description
DRUG	Minocycline Hydrochloride	Minocycline Hydrochloride 100 mg twice daily
DRUG	Placebo	Placebo

Timeline

• Start date: 2025-01-08
• Primary completion: 2028-07-01
• Completion: 2028-07-01
• First posted: 2024-02-07
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study