Neuroinflammation in Hypertension Study

Phase 3

Recruiting

• Conditions: Resistant Hypertension
• Interventions: Drug: Minocycline

• Registration Number: NCT04478500
• Lead Sponsor: Royal Perth Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2020-07-02
• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-20
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29
• Primary Completion: 2024-08-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Minocycline	Subjects will be randomized to receive placebo.
Minocycline Group	Minocycline	Subjects will be randomized to receive Minocycline 100mg twice daily

Primary Outcome Measures

Name	Time	Method
Assessment of change in central and peripheral inflammation	12 weeks	FDG PET
The difference in the daytime systolic blood pressure between groups after respective treatment.	12 weeks	Office and ambulatory blood pressures

Secondary Outcome Measures

Name	Time	Method
Change in muscle sympathetic nerve activity	12 weeks	Muscle sympathetic nerve activity assessed by microneurography
Change in central Blood Pressure	12 weeks	central Blood Pressure assessed by Sphygmocor XCEL

Trial Locations

Locations (1)

Royal Perth Hospital; 🇦🇺 Perth, Western Australia, Australia