Neuroinflammation in Hypertension Study

Study Overview
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Brief Summary
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To demonstrate that in patients with resistant hypertension oral treatment with minocycline via inhibition of central immune cell activation and inflammation results in reduced central sympathetic outflow and concomitant lowering of BP.

Detailed Description
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This is a randomized, double-blind, placebo controlled, parallel group design study aiming to compare the effects of minocycline 100mg twice daily vs matched placebo for 12 weeks on ambulatory BP and the parameters of sympathetic and immune activation

Official Title
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The Role of Neuroinflammation in Hypertension.Minocycline for Resistant Hypertension: a Randomized Double Blind Placebo-Controlled Trial

Conditions
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Resistant Hypertension

Intervention / Treatment
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* Drug: Minocycline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged: 45 -65 years Signed informed consent Clinical diagnosis of Resistant Hypertension Daytime systolic ambulatory BP >135mmHg. Exclusion Criteria:• eGFR of <45 mL/min/1.73m2 History of myocardial infarction (MI) or any cardiovascular event within 3 months of screening period, clinically significant AV conduction disturbances and/or arrhythmias, current of past history of heart failure (LVEF ≤40%) psychotropic agents, antidepressants and NSAIDS alcohol consumption of >3 standard drinks. known hypersensitivity or contraindication to minocycline or other tetracyclines.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Minocycline Group<br>Subjects will be randomized to receive Minocycline 100mg twice daily | Drug: Minocycline<br>* Participants will be randomly assigned to receive either Minocycline 100mg twice daily or Placebo. Comprehensive testing will be performed at baseline, and at the end of the 12 week intervention phase.<br>* Other names: Akamin;|
| Placebo Comparator: Placebo Group<br>Subjects will be randomized to receive placebo. | Drug: Minocycline<br>* Participants will be randomly assigned to receive either Minocycline 100mg twice daily or Placebo. Comprehensive testing will be performed at baseline, and at the end of the 12 week intervention phase.<br>* Other names: Akamin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The difference in the daytime systolic blood pressure between groups after respective treatment. | Office and ambulatory blood pressures | 12 weeks | 
| Assessment of change in central and peripheral inflammation | FDG PET | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle sympathetic nerve activity | Muscle sympathetic nerve activity assessed by microneurography | 12 weeks | 
| Change in central Blood Pressure | central Blood Pressure assessed by Sphygmocor XCEL | 12 weeks |