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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 27, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Markus Schlaich, Royal Perth Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Resistant Hypertension Drug: Minocycline Phase 3

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
Study Design
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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, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Minocycline Group
Subjects will be randomized to receive Minocycline 100mg twice daily
 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. The difference in the daytime systolic blood pressure between groups after respective treatment. [ Time Frame: 12 weeks ]
    Office and ambulatory blood pressures

  2. Assessment of change in central and peripheral inflammation [ Time Frame: 12 weeks ]
    FDG PET


Secondary Outcome Measures :
  1. Change in muscle sympathetic nerve activity [ Time Frame: 12 weeks ]
    Muscle sympathetic nerve activity assessed by microneurography

  2. Change in central Blood Pressure [ Time Frame: 12 weeks ]
    central Blood Pressure assessed by Sphygmocor XCEL


Eligibility Criteria
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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
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Revathy Carnagarin, MD +61892240316 revathy.carnagarin@uwa.edu.au
Contact: Omar Azzam, MD +61892242244 omar.azzam@health.wa.gov.au

Locations
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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         
Sponsors and Collaborators
Royal Perth Hospital
Investigators
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Principal Investigator: Markus Schlaich, MD University of Western Australia and Royal Perth Hospital
More Information
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Publications:

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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 27, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
 Minocycline
Anti-Bacterial Agents
Anti-Infective Agents