Neuroinflammation in Hypertension Study (MINIHT)

Royal Perth Hospital

Status and phase: Enrolling; Phase 3

Conditions: Resistant Hypertension

Treatments: Drug: Minocycline

Study type: Interventional

Funder types: Other

Identifiers

NCT04478500

DHC20180023

Details and patient eligibility

About

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.

Full description

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

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Minocycline Group

Active Comparator group

Description:

Subjects will be randomized to receive Minocycline 100mg twice daily

Treatment:

Drug: Minocycline

Placebo Group

Placebo Comparator group

Description:

Subjects will be randomized to receive placebo.

Treatment:

Drug: Minocycline