Other Clinical Trial - Antihypertensive Mechanisms of Minocycline in

Status Not yet recruiting

Clinical Trial 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 and are these effects different across races? - 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.

Clinical Trial Description

One hundred twenty patients (targeting 60 White patients and 60 Black or African American [AA] patients) with treatment-resistant hypertension will be enrolled. A total of 34 patients (17 from each treatment arm, with similar race distribution), 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. ;

Study Design

Related Conditions & MeSH terms

Hypertension
Hypertension, Resistant to Conventional Therapy

Clinical Trial Details

NCT number	NCT06246396
Study type	Interventional
Source	University of Florida
Contact	Dana Leach, DNP
Phone	352-273-8933
Email	leachdd@medicine.ufl.edu
Status	Not yet recruiting
Phase	Phase 4
Start date	April 1, 2024
Completion date	July 2028

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Antihypertensive Mechanisms of Minocycline in Resistant Hypertension

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms