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Neuroinflammation in Hypertension Study

PHASE3RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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.

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Eligibility

Age eligible for study : 45 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2020-07-02

Primary completion: 2024-08-01

Study completion finish: 2025-02-01

Study type

TREATMENT

Phase

PHASE3

Trial ID

NCT04478500

Intervention or treatment

DRUG: Minocycline

Conditions

• Resistant Hypertension

Condition: Resistant Hypertension
DRUG: Minocycline
Perth, Western Australia, Australia
Sponsor: Royal Perth Hospital

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Find a site

Closest Location:

Royal Perth Hospital

Research sites nearby

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Royal Perth Hospital
Perth, Western Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Minocycline Group Subjects will be randomized to receive Minocycline 100mg twice daily	DRUG: Minocycline 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.
PLACEBO_COMPARATOR: Placebo Group Subjects will be randomized to receive placebo.	DRUG: Minocycline 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.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome 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

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome 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

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Neuroinflammation in Hypertension Study