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Trial record 7 of 36 for:    Recruiting, Not yet recruiting, Suspended Studies | resistant hypertension

Neuroinflammation in Hypertension Study (MINIHT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04478500
Recruitment Status : Not yet recruiting
First Posted : July 20, 2020
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Markus Schlaich, Royal Perth Hospital

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

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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
Estimated Study Start Date : August 1, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine


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




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. Reduction in muscle sympathetic nerve activity [ Time Frame: 12 weeks ]
    Muscle sympathetic nerve activity assessed by microneurography

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



Information from the National Library of Medicine

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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.

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
Perth, Western Australia, Australia, 6000
Sponsors and Collaborators
Royal Perth Hospital
Investigators
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Principal Investigator: Markus Schlaich, MD University of Western Australia and Royal Perth Hospital
Publications:
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Responsible Party: Dr Markus Schlaich, Professor, Royal Perth Hospital
ClinicalTrials.gov Identifier: NCT04478500    
Other Study ID Numbers: 20180023
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
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