Neuroinflammation in Hypertension Study

NCT ID: NCT04478500

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-02

Study Completion Date

2025-02-01

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

Conditions

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Resistant Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Minocycline Group

Subjects will be randomized to receive Minocycline 100mg twice daily

Group Type ACTIVE_COMPARATOR

Minocycline

Intervention Type DRUG

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 Group

Subjects will be randomized to receive placebo.

Group Type PLACEBO_COMPARATOR

Minocycline

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Akamin

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

* 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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Perth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Markus Schlaich

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Schlaich, MD

Role: PRINCIPAL_INVESTIGATOR

University of Western Australia and Royal Perth Hospital

Locations

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Royal Perth Hospital

Perth, Western Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Revathy Carnagarin, MD

Role: CONTACT

+61892240316

Omar Azzam, MD

Role: CONTACT

+61892242244

Facility Contacts

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Anu Joyson, MSC RN

Role: primary

=08 922 ext. 40390

References

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Carnagarin R, Matthews V, Zaldivia MTK, Peter K, Schlaich MP. The bidirectional interaction between the sympathetic nervous system and immune mechanisms in the pathogenesis of hypertension. Br J Pharmacol. 2019 Jun;176(12):1839-1852. doi: 10.1111/bph.14481. Epub 2018 Sep 25.

Reference Type BACKGROUND
PMID: 30129037 (View on PubMed)

Santisteban MM, Ahmari N, Carvajal JM, Zingler MB, Qi Y, Kim S, Joseph J, Garcia-Pereira F, Johnson RD, Shenoy V, Raizada MK, Zubcevic J. Involvement of bone marrow cells and neuroinflammation in hypertension. Circ Res. 2015 Jul 3;117(2):178-91. doi: 10.1161/CIRCRESAHA.117.305853. Epub 2015 May 11.

Reference Type BACKGROUND
PMID: 25963715 (View on PubMed)

Other Identifiers

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DHC20180023

Identifier Type: -

Identifier Source: org_study_id

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