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Neuroinflammation in Hypertension Study (MINIHT)

Primary Purpose

Resistant Hypertension

Status

Recruiting

Phase

Phase 3

Locations

Australia

Study Type

Interventional

Intervention

Minocycline

About this trial

This is an interventional treatment trial for Resistant Hypertension

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Royal Perth HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Minocycline Group

Placebo Group

Arm Description

Subjects will be randomized to receive Minocycline 100mg twice daily

Subjects will be randomized to receive placebo.

Outcomes

Primary Outcome Measures

The difference in the daytime systolic blood pressure between groups after respective treatment.

Office and ambulatory blood pressures

Assessment of change in central and peripheral inflammation

FDG PET

Secondary Outcome Measures

Change in muscle sympathetic nerve activity

Muscle sympathetic nerve activity assessed by microneurography

Change in central Blood Pressure

central Blood Pressure assessed by Sphygmocor XCEL

Full Information

NCT ID

NCT04478500

First Posted

July 10, 2020

Last Updated

September 28, 2022

Sponsor

Royal Perth Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04478500

Brief Title

Neuroinflammation in Hypertension Study

Acronym

MINIHT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 2, 2020 (Actual)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Royal Perth Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Resistant Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Minocycline Group

Arm Type

Active Comparator

Arm Description

Subjects will be randomized to receive Minocycline 100mg twice daily

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

Subjects will be randomized to receive placebo.

Intervention Type

Drug

Intervention Name(s)

Minocycline

Other Intervention Name(s)

Akamin

Intervention Description

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.

Primary Outcome Measure Information:

Title

The difference in the daytime systolic blood pressure between groups after respective treatment.

Description

Office and ambulatory blood pressures

Time Frame

12 weeks

Title

Assessment of change in central and peripheral inflammation

Description

FDG PET

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Change in muscle sympathetic nerve activity

Description

Muscle sympathetic nerve activity assessed by microneurography

Time Frame

12 weeks

Title

Change in central Blood Pressure

Description

central Blood Pressure assessed by Sphygmocor XCEL

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Revathy Carnagarin, MD

Phone

+61892240316

revathy.carnagarin@uwa.edu.au

First Name & Middle Initial & Last Name or Official Title & Degree

Omar Azzam, MD

Phone

+61892242244

omar.azzam@health.wa.gov.au

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus Schlaich, MD

Organizational Affiliation

University of Western Australia and Royal Perth Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Royal Perth Hospital

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6000

Country

Australia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anu Joyson, MSC RN

Phone

=08 922

Ext

40390

anu.joyson@uwa.edu.au

First Name & Middle Initial & Last Name & Degree

Markus Schlaich, Prof

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30129037

Citation

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.

Results Reference

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PubMed Identifier

25963715

Citation

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.

Results Reference

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Neuroinflammation in Hypertension Study

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