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RecruitingPhase 4

Antihypertensive Mechanisms of Minocycline in Resistant Hypertension

Antihypertensive Mechanisms of Minocycline in Resistant Hypertension: Role of the Gut Microbiota-brain-immune Axis

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 3 visits
  • Time periods mentioned: 3 months
  • Procedures mentioned: Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be randomly assigned to treatment with minocycline or placebo, treated daily for 3 months, to evaluate these questions."
  • "The study will last 3 months, and will include 3 visit time points (screening, randomization visit, 3-month follow-up visit)."
  • "At the final visit (3-month follow-up), participants will also have blood tests to measure study drug concentration, as a measure of adherence to the assigned treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how much minocycline lowers blood pressure in adults whose blood pressure stays high despite treatment. It also looks at whether changes in gut bacteria, gut leakiness, or inflammation in the body or brain explain its effects. Participants are assigned by chance to take minocycline or a placebo (a pill with no study drug) daily for 3 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • Your average blood pressure over 24 hours is at least 125 for the top number or 80 for the bottom number, despite taking at least 3 blood pressure medicines as directed.
  • Your blood pressure medicines have not changed for at least 14 days. They include a water pill at an adequate dose, unless you cannot tolerate one.
  • You agree to all study tests and procedures.

Who can't join

  • You have an allergy to minocycline or other tetracycline antibiotics, or a medical reason you cannot take them.
  • You took antibiotics by mouth in the past 3 months, take them now, or expect to take them during the study.
  • Your kidney filtering test result (eGFR) is below 45, or your high blood pressure has a known underlying cause.
  • You were admitted to a hospital for dangerously high blood pressure in the past year.
  • In the past year, you had at least 2 episodes when standing caused your blood pressure to drop within 3 minutes by more than 20 in the top number or 10 in the bottom number.
  • You had a heart attack, unstable angina (new or worsening heart-related chest pain), fainting, or a stroke in the past 6 months.
  • There is evidence of alcohol or drug abuse, or you have a serious illness such as a tumor, HIV, or AIDS.
  • You are pregnant now or expect to become pregnant during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

FL