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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT04478500
Ethics application status
Date submitted
10/07/2020
Date registered
20/07/2020
Date last updated
29/09/2022

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
DHC20180023
Universal Trial Number (UTN)
Trial acronym
MINIHT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resistant Hypertension 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
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

Outcomes
Primary outcome [1] 0 0
The difference in the daytime systolic blood pressure between groups after respective treatment.
Timepoint [1] 0 0
12 weeks
Primary outcome [2] 0 0
Assessment of change in central and peripheral inflammation
Timepoint [2] 0 0
12 weeks
Secondary outcome [1] 0 0
Change in muscle sympathetic nerve activity
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Change in central Blood Pressure
Timepoint [2] 0 0
12 weeks

Eligibility
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
Sex
Both males and females
Can healthy volunteers participate?
No
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 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
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
2/07/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
6000 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Perth Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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
https://clinicaltrials.gov/study/NCT04478500
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.
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

Contacts
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
+61892240316
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

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