NCT04478500

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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2020

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 2, 2020

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

4.1 years

First QC Date

July 10, 2020

Last Update Submit

September 28, 2022

Conditions

Resistant Hypertension

Outcome Measures

Primary Outcomes (2)

  • The difference in the daytime systolic blood pressure between groups after respective treatment.

    Office and ambulatory blood pressures

    12 weeks

  • Assessment of change in central and peripheral inflammation

    FDG PET

    12 weeks

Secondary Outcomes (2)

  • Change in muscle sympathetic nerve activity

    12 weeks

  • Change in central Blood Pressure

    12 weeks

Study Arms (2)

Minocycline Group

ACTIVE COMPARATOR

Subjects will be randomized to receive Minocycline 100mg twice daily

Drug: Minocycline

Placebo Group

PLACEBO COMPARATOR

Subjects will be randomized to receive placebo.

Drug: Minocycline

Interventions

MinocyclineDRUG

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.

Also known as: Akamin
Minocycline GroupPlacebo Group

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged: 45 -65 years
  • Signed informed consent
  • Clinical diagnosis of Resistant Hypertension
  • Daytime systolic ambulatory BP \>135mmHg.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 30129037BACKGROUND

  • 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.

    PMID: 25963715BACKGROUND

MeSH Terms

Interventions

Minocycline

Intervention Hierarchy (Ancestors)

TetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Markus Schlaich, MD

    University of Western Australia and Royal Perth Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Revathy Carnagarin, MD

CONTACT

+61892240316revathy.carnagarin@uwa.edu.au

Omar Azzam, MD

CONTACT

+61892242244omar.azzam@health.wa.gov.au

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 20, 2020

Study Start

July 2, 2020

Primary Completion

August 1, 2024

Study Completion

February 1, 2025

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)