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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04478500

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Neuroinflammation in Hypertension Study
Scientific title
The Role of Neuroinflammation in Hypertension.Minocycline for Resistant Hypertension: a Randomized Double Blind Placebo-Controlled Trial
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Minocycline

Active Comparator: Minocycline Group - Subjects will be randomized to receive Minocycline 100mg twice daily

Placebo Comparator: Placebo Group - Subjects will be randomized to receive placebo.

Treatment: Drugs: 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 code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
The difference in the daytime systolic blood pressure between groups after respective treatment. - Office and ambulatory blood pressures
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Assessment of change in central and peripheral inflammation - FDG PET
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Change in muscle sympathetic nerve activity - Muscle sympathetic nerve activity assessed by microneurography
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Change in central Blood Pressure - central Blood Pressure assessed by Sphygmocor XCEL
Timepoint [2] 0 0
12 weeks

Key inclusion criteria
- Aged: 45 -65 years

- Signed informed consent

- Clinical diagnosis of Resistant Hypertension

- Daytime systolic ambulatory BP >135mmHg.
Minimum age
45 Years
Maximum age
65 Years
Both males and females
Can healthy volunteers participate?
Key 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

- 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
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Royal Perth Hospital

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
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. Review.
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.
Public notes

Principal investigator
Name 0 0
Markus Schlaich, MD
Address 0 0
University of Western Australia and Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Revathy Carnagarin, MD
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04478500