NOT_YET_RECRUITING
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension
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.
Conditions:
🦠 Hypertension, Resistant to Conventional Therapy
🗓️ Study Start (Actual) 1 October 2024
🗓️ Primary Completion (Estimated) July 2028
✅ Study Completion (Estimated) July 2028
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE4
Locations:
📍 Gainesville, Florida, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age ≥18 years
    • * Self-identify as White or African American
    • * 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 ≥30 days prior) antihypertensive regimen of 3 or more drugs, including an adequately dosed thiazide or thiazide-like diuretic (hydrochlorothiazide ≥25 mg/day or equivalent)
    • * 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 antihypertensive crisis, defined as any in-patient hospitalizations for antihypertensive 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)
    • * Ongoing or expected use of significant BP-interfering medications (excepting oral contraceptives)
    • * Current pregnancy or anticipated pregnancy during the study.
Ages Eligible for Study: 18 Years to 85 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 30 January 2024
  • First Submitted that Met QC Criteria 30 January 2024
  • First Posted 7 February 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 22 July 2024
  • Last Update Posted 23 July 2024
  • Last Verified July 2024