Neuroinflammation in Hypertension Study (MINIHT)
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ClinicalTrials.gov Identifier: NCT04478500 |
Recruitment Status :
Recruiting
First Posted : July 20, 2020
Last Update Posted : September 29, 2022
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Condition or disease | Intervention/treatment | Phase |
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Resistant Hypertension | Drug: Minocycline | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | The Role of Neuroinflammation in Hypertension.Minocycline for Resistant Hypertension: a Randomized Double Blind Placebo-Controlled Trial |
Actual Study Start Date : | July 2, 2020 |
Estimated Primary Completion Date : | August 1, 2024 |
Estimated Study Completion Date : | February 1, 2025 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Minocycline Group
Subjects will be randomized to receive Minocycline 100mg twice daily
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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. Other Name: Akamin |
Placebo Comparator: Placebo Group
Subjects will be randomized to receive placebo.
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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. Other Name: Akamin |
- The difference in the daytime systolic blood pressure between groups after respective treatment. [ Time Frame: 12 weeks ]Office and ambulatory blood pressures
- Assessment of change in central and peripheral inflammation [ Time Frame: 12 weeks ]FDG PET
- Change in muscle sympathetic nerve activity [ Time Frame: 12 weeks ]Muscle sympathetic nerve activity assessed by microneurography
- Change in central Blood Pressure [ Time Frame: 12 weeks ]central Blood Pressure assessed by Sphygmocor XCEL

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Ages Eligible for Study: | 45 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04478500
Contact: Revathy Carnagarin, MD | +61892240316 | revathy.carnagarin@uwa.edu.au | |
Contact: Omar Azzam, MD | +61892242244 | omar.azzam@health.wa.gov.au |
Australia, Western Australia | |
Royal Perth Hospital | Recruiting |
Perth, Western Australia, Australia, 6000 | |
Contact: Anu Joyson, MSC RN =08 922 ext 40390 anu.joyson@uwa.edu.au | |
Principal Investigator: Markus Schlaich, Prof |
Principal Investigator: | Markus Schlaich, MD | University of Western Australia and Royal Perth Hospital |
Responsible Party: | Dr Markus Schlaich, Professor, Royal Perth Hospital |
ClinicalTrials.gov Identifier: | NCT04478500 |
Other Study ID Numbers: |
DHC20180023 |
First Posted: | July 20, 2020 Key Record Dates |
Last Update Posted: | September 29, 2022 |
Last Verified: | September 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hypertension Vascular Diseases Cardiovascular Diseases |
Minocycline Anti-Bacterial Agents Anti-Infective Agents |