Recruiting

Minocycline

Sponsor:

University of Florida

Code:

NCT06246396

Conditions

Hypertension, Resistant to Conventional Therapy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Minocycline Hydrochloride

Placebo

Study Details

Brief 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.

Conditions

Hypertension, Resistant to Conventional Therapy

Study ID

NCT06246396

Start date

Jan 8, 2025

Status verified date

Mar, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥18 years
  • Uncontrolled TRH, defined as uncontrolled blood pressure (mean 24-hour ambulatory systolic BP ≥125 mm Hg or diastolic BP ≥80 mm Hg) while being adherent to a stable (no changes in ≥14 days prior) antihypertensive regimen of 3 or more drugs, including an adequately dosed diuretic or unable to tolerate a diuretic.
  • The participant agrees to have all study procedures performed

Exclusion Criteria:

  • Known hypersensitivity or contraindication to minocycline or other tetracyclines
  • Recent (≤3 months prior), ongoing, or expected use of oral antibiotics
  • Estimated glomerular filtration rate (eGFR) of <45mL/min/1.73m2, using the MDRD equation
  • Known secondary hypertension
  • History of hypertensive crisis, defined as any in-patient hospitalizations for hypertensive crisis/emergency within the past year
  • History of orthostatic hypotension, defined as two or more episode(s) of orthostatic hypotension (reduction of SBP of >20 mm Hg or DBP of >10 mm Hg within 3 minutes of standing) in the past year
  • History of myocardial infarction, unstable angina, syncope, or cerebrovascular accident in prior 6 months
  • Evidence of alcoholism or drug abuse
  • Severe comorbid conditions (i.e., neoplasms or HIV positive or AIDS)
  • Current pregnancy or anticipated pregnancy during the study.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Minocycline Hydrochloride

Minocycline hydrochloride 100 mg, administered twice daily for 3 months

placebo comparator: Placebo

Placebo administered twice daily for 3 months

Interventions

Minocycline Hydrochloride

Minocycline Hydrochloride 100 mg twice daily

Placebo

Placebo

Primary outcome measure

  • 24-h systolic blood pressure [ Time Frame: 3 months ]
  • Gut microbiome [ Time Frame: 3 months ]
  • Gut inflammation and leakiness [ Time Frame: 3 months ]
  • Neuroinflammation [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Joshua N Terrell

352-294-8297jterrell5102@ufl.edu

David B Smith

352-294-8297dbsmith@cop.ufl.edu

Locations

UF Clinical Research Center (UF CRC) - CTSI

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Joshua N Terrell

352-294-8297jterrell5102@ufl.edu

David B Smith

352-294-8297dbsmith@cop.ufl.edu

Principal Investigator:

Carl J Pepine, MD

More Information

Sponsor

University of Florida

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

  • minocycline
  • blood pressure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by University of Florida on 2026-03-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.