Central Sympathetic Nervous System DiseasesPhase 4NCT04479813
Role of Sympathetic Activation in Ischemia Reperfusion Injury
A Phase 4 study testing Moxonidine 0.2 MG in people with Central Sympathetic Nervous System Diseases, run by Royal Perth Hospital at 1 site in Australia.
Trial summary
This study is designed to assess the effect of forearm ischemia-reperfusion injury on sympathetic nerve activity. To determine whether reduced sympathetic responsiveness is a contributor to the protective effects of remote ischemic preconditioning. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Central Sympathetic Nervous System Diseases
- What is being tested?
- Moxonidine 0.2 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 1 siteAustralia
- Study dates
- 8 Jul 2015to 1 Mar 2022
- Phase
- Phase 4
- 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 18 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy males, not on any medication, free of any history of metabolic, cardiovascular or cerebrovascular disease.
Who cannot join
- smoker
Trial locations and contacts
1 site in 1 country.
About this study
This study is designed to assess the effect of forearm ischemia-reperfusion injury on sympathetic nerve activity. To determine whether reduced sympathetic responsiveness is a contributor to the protective effects of remote ischemic preconditioning. In addition it will assess whether pharmacologic inhibition of the sympathetic nervous system can ameliorate ischemia reperfusion injury induced endothelial dysfunction.
Read the detailed description
This is a randomized single blind study where subjects will be allocated to undergo one of the 4 protocols. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.
This medication acts by reducing the activity of nerves believed to be involved in the conditioning process. The placebo pill, designed to have no effect, will be used as a comparison. Comprehensive tests will occur which include Microneurography, Endothelial function ,Blood Sampling, Temporary block of arm blood flow and Remote conditioning
- Being tested
- Moxonidine 0.2 MG, placebo
- Keywords
- Ischemia, re-perfusion, Remote conditioning
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxonidine 0.2 MGDrug
Subjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.
placeboOther
Subjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.
| Study group | Role | What they receive |
|---|---|---|
| No conditioning + placebo | Experimental | Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests. Receives: Other: placebo |
| No conditioning + moxonidine | Experimental | Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests. Receives: Drug: Moxonidine 0.2 MG |
| Remote pre-conditioning + placebo | Experimental | Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests. Receives: Other: placebo |
| Remote pre-conditioning + moxonidine | Experimental | Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests. Receives: Drug: Moxonidine 0.2 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in muscle sympathetic nerve activity
Muscle sympathetic nerve activity assessed by microneurography
Measured: 1 day
Secondary outcomes (1)
Endothelial Function using the EndoPat2000 device
Endothelial Function testing involves the measurement of pulse amplitude from the tip of each index finger at rest and after a period of occlusion using an arm cuff that is manually inflated to a level above that of the participant's Blood Pressure (BP).
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start8 Jul 2015
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Sympathetic Nervous System DiseasesStudies 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 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
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,FAHA,FESC, Principal investigator, Royal Perth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479813
- Sponsor's protocol ID
- REG 15-021
- Status last verified
- Sep 2022
- First submitted
- 16 Jul 2020
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Role of Sympathetic Activation in Ischemia Reperfusion Injury
- ClinicalTrials.gov ID
- NCT04479813
- Acronym / sponsor ID
- REG 15-021
- Keywords
- Ischemia, re-perfusion, Remote conditioning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Royal Perth HospitalUniversity, hospital or other
- Study start
- 8 Jul 2015 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 21 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.
This study is designed to assess the effect of forearm ischemia-reperfusion injury on sympathetic nerve activity. To determine whether reduced sympathetic responsiveness is a contributor to the protective effects of remote ischemic preconditioning. In addition it will assess whether pharmacologic inhibition of the sympathetic nervous system can ameliorate ischemia reperfusion injury induced endothelial dysfunction.
Detailed description
This is a randomized single blind study where subjects will be allocated to undergo one of the 4 protocols. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.
This medication acts by reducing the activity of nerves believed to be involved in the conditioning process. The placebo pill, designed to have no effect, will be used as a comparison. Comprehensive tests will occur which include Microneurography, Endothelial function ,Blood Sampling, Temporary block of arm blood flow and Remote conditioning
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| No conditioning + placebo | Experimental | Other: placeboParticipants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests. |
| No conditioning + moxonidine | Experimental | Drug: Moxonidine 0.2 MGParticipants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests. |
| Remote pre-conditioning + placebo | Experimental | Other: placeboParticipants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests. |
| Remote pre-conditioning + moxonidine | Experimental | Drug: Moxonidine 0.2 MGParticipants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy males, not on any medication, free of any history of metabolic, cardiovascular or cerebrovascular disease.
Key exclusion criteria (1 listed)
- smoker
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 |
|---|---|---|
| Moxonidine 0.2 MGSubjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement. | Drug | No conditioning + moxonidine, Remote pre-conditioning + moxonidine |
| placeboSubjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement. | Other | No conditioning + placebo, Remote pre-conditioning + placebo |
Primary outcome
change in muscle sympathetic nerve activity
Time frame: 1 day
Muscle sympathetic nerve activity assessed by microneurography
1 secondary outcome
Endothelial Function using the EndoPat2000 device
Time frame: 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
Related trials for Central Sympathetic Nervous System Diseases
Not yet recruiting
Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Delayed Cerebral Ischemia
Recruiting
Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.
Spinal Cord Injuries (SCI), Spinal Cord Injury
RecruitingPhase 2
18F-mFBG Cardiac Uptake With Lewy Body Dementia
Parkinson Disease (PD), Lewy Body Dementia (LBD)
Recruiting
Transauricular Vagus Nerve Stimulation for Chronic Whiplash Associated Disorders
Whiplash Associated Disorder (WAD)
RecruitingObservational study
Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospective Case Series
PTSD, Trauma-related Mental Health Symptoms
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,FAHA,FESC principal investigator
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 4 study testing Moxonidine 0.2 MG in people with Central Sympathetic Nervous System Diseases, 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 1 inclusion and 1 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: finished, 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in muscle sympathetic nerve activity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.