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MINIHT: Neuroinflammation in Hypertension Study

Sponsor
Royal Perth Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04478500
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
31
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
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

Study Type:
Interventional
Anticipated 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 :
Jul 2, 2020
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Feb 1, 2023

Arms and Interventions

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 Names:
  • 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 Names:
  • Akamin

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The difference in the daytime systolic blood pressure between groups after respective treatment. [12 weeks]

      Office and ambulatory blood pressures

    2. Assessment of change in central and peripheral inflammation [12 weeks]

      FDG PET

    Secondary Outcome Measures

    1. Change in muscle sympathetic nerve activity [12 weeks]

      Muscle sympathetic nerve activity assessed by microneurography

    2. Change in central Blood Pressure [12 weeks]

      central Blood Pressure assessed by Sphygmocor XCEL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 65 Years
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Perth Hospital Perth Western Australia Australia 6000

    Sponsors and Collaborators

    • Royal Perth Hospital

    Investigators

    • Principal Investigator: Markus Schlaich, MD, University of Western Australia and Royal Perth Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr Markus Schlaich, Professor, Royal Perth Hospital
    ClinicalTrials.gov Identifier:
    NCT04478500
    Other Study ID Numbers:
    • DHC20180023
    First Posted:
    Jul 20, 2020
    Last Update Posted:
    Sep 27, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Minocycline

    Study Results

    No Results Posted as of Sep 27, 2021