Effects of minocycline on blood pressure in resistant hypertension
Antihypertensive Mechanisms of Minocycline in Resistant Hypertension: Role of the Gut Microbiota-brain-immune Axis
This study is testing if the antibiotic minocycline can lower blood pressure in people who have high blood pressure that doesn't respond to usual treatments, and whether the results differ by race.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06246396 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates how minocycline affects blood pressure in individuals with treatment-resistant hypertension. It aims to determine the extent of blood pressure reduction and whether these effects vary by race. Participants will be randomly assigned to receive either minocycline or a placebo for three months, with various assessments including blood tests, gut microbiota profiling, and blood pressure measurements. A subset of participants will also undergo neuroimaging to explore potential mechanisms behind the treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who self-identify as White or African American and have uncontrolled treatment-resistant hypertension despite being on multiple antihypertensive medications.
Not a fit: Patients with known hypersensitivity to minocycline, recent antibiotic use, or secondary hypertension may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with resistant hypertension.
How similar studies have performed: While the specific use of minocycline for resistant hypertension is novel, similar studies exploring the role of gut microbiota and inflammation in hypertension have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gainesville, Florida
- UF Clinical Research Center (UF CRC) - CTSI — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Steven M Smith, PharmD, MPH — University of Florida
- Study coordinator: Joshua N Terrell
- Email: jterrell5102@ufl.edu
- Phone: 352-294-8297
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.