Back to resultsRole of Sympathetic Activation in Ischemia Reperfusion Injury
Primary Purpose
Central Sympathetic Nervous System Diseases
Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Moxonidine 0.2 MG
placebo
Sponsored by
About this trial
This is an interventional basic science trial for Central Sympathetic Nervous System Diseases focused on measuring Ischemia, re-perfusion, Remote conditioning
Eligibility Criteria
Inclusion Criteria:
- healthy males, not on any medication, free of any history of metabolic, cardiovascular or cerebrovascular disease.
Exclusion Criteria:
- smoker
Sites / Locations
- Dobney Hypertension Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
No conditioning + placebo
No conditioning + moxonidine
Remote pre-conditioning + placebo
Remote pre-conditioning + moxonidine
Arm Description
Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.
Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.
Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.
Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.
Outcomes
Primary Outcome Measures
change in muscle sympathetic nerve activity
Muscle sympathetic nerve activity assessed by microneurography
Secondary Outcome Measures
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04479813
Brief Title
Role of Sympathetic Activation in Ischemia Reperfusion Injury
Official Title
Role of Sympathetic Activation in Ischemia Reperfusion Injury
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2015 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Perth Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Sympathetic Nervous System Diseases
Keywords
Ischemia, re-perfusion, Remote conditioning
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No conditioning + placebo
Arm Type
Experimental
Arm Description
Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.
Arm Title
No conditioning + moxonidine
Arm Type
Experimental
Arm Description
Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.
Arm Title
Remote pre-conditioning + placebo
Arm Type
Experimental
Arm Description
Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.
Arm Title
Remote pre-conditioning + moxonidine
Arm Type
Experimental
Arm Description
Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.
Intervention Type
Drug
Intervention Name(s)
Moxonidine 0.2 MG
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in muscle sympathetic nerve activity
Description
Muscle sympathetic nerve activity assessed by microneurography
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Endothelial Function using the EndoPat2000 device
Description
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).
Time Frame
2 days
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
50 healthy male volunteers (25 aged 18-30 years and 25 aged 60-75 years)
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy males, not on any medication, free of any history of metabolic, cardiovascular or cerebrovascular disease.
Exclusion Criteria:
smoker
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Markus Schlaich, MD,FAHA,FESC
Organizational Affiliation
Royal Perth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dobney Hypertension Centre
City
Perth
Country
Australia
12. IPD Sharing Statement
Learn more about this trial
Role of Sympathetic Activation in Ischemia Reperfusion Injury
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