NCT06246396

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
26mo left

Started Jan 2025

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress38%
Jan 2025Jul 2028

First Submitted

Initial submission to the registry

January 30, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2024

Completed
11 months until next milestone

Study Start

First participant enrolled

January 8, 2025

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

January 30, 2024

Last Update Submit

March 5, 2026

Conditions

Hypertension, Resistant to Conventional Therapy

Keywords

minocyclineblood pressure

Outcome Measures

Primary Outcomes (4)

  • 24-h systolic blood pressure

    Change in mean 24-hour ambulatory systolic blood pressure

    3 months

  • Gut microbiome

    Change in butyrate-producing gene abundance

    3 months

  • Gut inflammation and leakiness

    Change in gut-homing inflammatory T-helper cells

    3 months

  • Neuroinflammation

    Change in \[18F\]FEPPA radiotracer uptake on PET/MR imaging

    3 months

Secondary Outcomes (6)

  • Mucin-degrading gene abundance

    3 months

  • IgA+ coated plasma cells

    3 months

  • Gut leakiness markers

    3 months

  • 24-h diastolic blood pressure

    3 months

  • 24-h heart rate

    3 months

  • +1 more secondary outcomes

Study Arms (2)

Minocycline Hydrochloride

EXPERIMENTAL

Minocycline hydrochloride 100 mg, administered twice daily for 3 months

Drug: Minocycline Hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo administered twice daily for 3 months

Drug: Placebo

Interventions

Minocycline HydrochlorideDRUG

Minocycline Hydrochloride 100 mg twice daily

Also known as: Minocycline, Minocin
Minocycline Hydrochloride
PlaceboDRUG

Placebo

Placebo

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UF Clinical Research Center (UF CRC) - CTSI

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Hypertension Resistant to Conventional Therapycyclopia sequence

Interventions

Minocycline

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Steven M Smith, PharmD, MPH

    University of Florida

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua N Terrell

CONTACT

352-294-8297jterrell5102@ufl.edu

David B Smith

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 7, 2024

Study Start

January 8, 2025

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

March 6, 2026

Record last verified: 2026-03

Locations

US(1)