Role of Sympathetic Activation in Ischemia Reperfusion Injury

Sponsor

Royal Perth Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04479813

Collaborator

(none)

Enrollment

Location

Arms

88.8

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Central Sympathetic Nervous System Diseases	Drug: Moxonidine 0.2 MG Other: placebo	Phase 4

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

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Role of Sympathetic Activation in Ischemia Reperfusion Injury

Actual Study Start Date :

Jul 8, 2015

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: No conditioning + placebo Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.	Other: placebo 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.
Experimental: No conditioning + moxonidine Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.	Drug: Moxonidine 0.2 MG 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.
Experimental: Remote pre-conditioning + placebo Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.	Other: placebo 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.
Experimental: Remote pre-conditioning + moxonidine Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.	Drug: Moxonidine 0.2 MG 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.

Outcome Measures

Primary Outcome Measures

change in muscle sympathetic nerve activity [1 day]
Muscle sympathetic nerve activity assessed by microneurography

Secondary Outcome Measures

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).