NCT06246396 Antihypertensive Mechanisms of Minocycline in Resistant Hypertension
| NCT ID | NCT06246396 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of Florida |
| Condition | Hypertension, Resistant to Conventional Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-01-08 |
| Primary Completion | 2028-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2025-01-08 with a primary completion date of 2028-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Steven M Smith, PharmD, MPH
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT06246396 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Hypertension, Resistant to Conventional Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06246396 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06246396 currently recruiting?
Yes, NCT06246396 is actively recruiting participants. Contact the research team at jterrell5102@ufl.edu for enrollment information.
Where is the NCT06246396 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT06246396 clinical trial?
NCT06246396 is sponsored by University of Florida. The principal investigator is Steven M Smith, PharmD, MPH at University of Florida. The trial plans to enroll 120 participants.