Resistant HypertensionPhase 3MINIHTNCT04478500
Neuroinflammation in Hypertension Study
A Phase 3 study testing Minocycline in people with Resistant Hypertension, run by Royal Perth Hospital at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Resistant Hypertension
- What is being tested?
- Minocycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 2 Jul 2020to 1 Feb 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged: 45 -65 years
- Signed informed consent
- Clinical diagnosis of Resistant Hypertension
- Daytime systolic ambulatory BP >135mmHg.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Royal Perth Hospital
Perth, Western Australia, 6000
Anu Joyson, MSC RN, =08 922 ext. 40390, anu.joyson@uwa.edu.au
Markus Schlaich, Prof
About this study
Official title: The Role of Neuroinflammation in Hypertension.Minocycline for Resistant Hypertension: a Randomized Double Blind Placebo-Controlled Trial
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.
Read the 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
- Conditions
- Resistant Hypertension
- Being tested
- Minocycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Akamin
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.
| Study group | Role | What they receive |
|---|---|---|
| Minocycline Group | Active comparator | Subjects will be randomized to receive Minocycline 100mg twice daily Receives: Drug: Minocycline |
| Placebo Group | Placebo comparator | Subjects will be randomized to receive placebo. Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the daytime systolic blood pressure between groups after respective treatment.
Office and ambulatory blood pressures
Measured: 12 weeks
Assessment of change in central and peripheral inflammation
FDG PET
Measured: 12 weeks
Secondary outcomes (2)
Change in muscle sympathetic nerve activity
Muscle sympathetic nerve activity assessed by microneurography
Measured: 12 weeks
Change in central Blood Pressure
central Blood Pressure assessed by Sphygmocor XCEL
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start2 Jul 2020
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Resistant HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Perth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Markus Schlaich, Royal Perth Hospital
- Investigators
- Markus Schlaich, MD, Principal investigator, University of Western Australia and Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478500
- Sponsor's protocol ID
- DHC20180023
- Acronym
- MINIHT
- Status last verified
- Sep 2022
- First submitted
- 10 Jul 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30129037Santisteban 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.
PubMed 25963715
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Neuroinflammation in Hypertension.Minocycline for Resistant Hypertension: a Randomized Double Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT04478500
- Acronym / sponsor ID
- MINIHT / DHC20180023
- Conditions
- Resistant Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Royal Perth HospitalUniversity, hospital or other
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline Group | Active comparator | Drug: MinocyclineSubjects will be randomized to receive Minocycline 100mg twice daily |
| Placebo Group | Placebo comparator | Drug: MinocyclineSubjects will be randomized to receive placebo. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged: 45 -65 years
- Signed informed consent
- Clinical diagnosis of Resistant Hypertension
- Daytime systolic ambulatory BP >135mmHg.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineAlso: AkaminParticipants 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. | Drug | Minocycline Group, Placebo Group |
Primary outcome
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
2 secondary outcomes
Change in muscle sympathetic nerve activity
Time frame: 12 weeks
Change in central Blood Pressure
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Background: PubMed 30129037Carnagarin 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.
- Background: PubMed 25963715Santisteban 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Schlaich, MD principal investigator
University of Western Australia and Royal Perth Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minocycline in people with Resistant Hypertension, run by Royal Perth Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Revathy Carnagarin, MD (+61892240316, revathy.carnagarin@uwa.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the daytime systolic blood pressure between groups after respective treatment. (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04478500, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.