Health TrialsbyHealthPanel

Antihypertensive Mechanisms of Minocycline in Resistant Hypertension

ConditionHypertension, Resistant to Conventional Therapy
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Florida

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minocycline Hydrochloride

    Drug

    Minocycline Hydrochloride 100 mg twice daily

  • Placebo

    Drug

    Placebo

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Minocycline HydrochlorideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

24-h systolic blood pressure

Change in mean 24-hour ambulatory systolic blood pressure

Time frame
3 months
2

Gut microbiome

Change in butyrate-producing gene abundance

Time frame
3 months
3

Gut inflammation and leakiness

Change in gut-homing inflammatory T-helper cells

Time frame
3 months
4

Neuroinflammation

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

Time frame
3 months

Secondary outcomes

1

Mucin-degrading gene abundance

Change in mucin-degrading gene abundance

Time frame
3 months
2

IgA+ coated plasma cells

Change in IgA+ coated plasma cells

Time frame
3 months
3

Gut leakiness markers

Change in gut leakiness markers, including lipocalin-2, intestinal fatty-acid binding protein (I-FABP), zonulin, and lipopolysaccharides (LPS)

Time frame
3 months
4

24-h diastolic blood pressure

Change in mean 24-hour diastolic blood pressure

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Florida

Lead sponsor

Emory University

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Source ClinicalTrials.gov
Apply now