Role of Sympathetic Activation in Ischemia Reperfusion Injury

Central Sympathetic Nervous System Diseases Clinical Trial

Official title:

Role of Sympathetic Activation in Ischemia Reperfusion Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479813
• Other study ID #: REG 15-021
• Status: Completed
• Phase: Phase 4
• Start date: July 8, 2015
• Est. completion date: March 1, 2022

Study information

• Verified date: September 2022
• Source: Royal Perth Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. In addition it will assess whether pharmacologic inhibition of the sympathetic nervous system can ameliorate ischemia reperfusion injury induced endothelial dysfunction.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• smoker

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Central Sympathetic Nervous System Diseases
• Ischemia
• Nervous System Diseases
• Reperfusion Injury

Intervention

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.

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.

Locations

Country	Name	City	State
Australia	Dobney Hypertension Centre	Perth

Sponsors (1)

Lead Sponsor	Collaborator
Royal Perth Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in muscle sympathetic nerve activity	Muscle sympathetic nerve activity assessed by microneurography	1 day
Secondary	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).	2 days