Role of Sympathetic Activation in Ischemia Reperfusion Injury

Phase 4

Completed

• Conditions: Central Sympathetic Nervous System Diseases
• Interventions: Other: placebo; Drug: Moxonidine 0.2 MG

• Registration Number: NCT04479813
• Lead Sponsor: Royal Perth Hospital

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

Study Timeline

• Study Start: 2015-07-08
• Study First Submitted: 2020-07-16
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-21
• Primary Completion: 2022-03-01
• Study Completion: 2022-03-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-28
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

Inclusion Criteria

• healthy males, not on any medication, free of any history of metabolic, cardiovascular or cerebrovascular disease.

Exclusion Criteria

• smoker

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
No conditioning + placebo	placebo	Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.
No conditioning + moxonidine	Moxonidine 0.2 MG	Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.
Remote pre-conditioning + placebo	placebo	Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.
Remote pre-conditioning + moxonidine	Moxonidine 0.2 MG	Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.

Primary Outcome Measures

Name	Time	Method
change in muscle sympathetic nerve activity	1 day	Muscle sympathetic nerve activity assessed by microneurography

Secondary Outcome Measures

Name	Time	Method
Endothelial Function using the EndoPat2000 device	2 days	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).

Trial Locations

Locations (1)

Dobney Hypertension Centre; 🇦🇺 Perth, Australia