Role of Sympathetic Activation in Ischemia Reperfusion Injury

NCT ID: NCT04479813

Last Updated: 2022-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-08

Study Completion Date

2022-03-01

Brief Summary

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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

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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

Conditions

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Central Sympathetic Nervous System Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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No conditioning + placebo

Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.

Group Type EXPERIMENTAL

placebo

Intervention Type OTHER

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.

No conditioning + moxonidine

Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.

Group Type EXPERIMENTAL

Moxonidine 0.2 MG

Intervention Type DRUG

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.

Remote pre-conditioning + placebo

Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.

Group Type EXPERIMENTAL

placebo

Intervention Type OTHER

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.

Remote pre-conditioning + moxonidine

Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement with conditioning tests.

Group Type EXPERIMENTAL

Moxonidine 0.2 MG

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* smoker
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Royal Perth Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr Markus Schlaich

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Markus Schlaich, MD,FAHA,FESC

Role: PRINCIPAL_INVESTIGATOR

Royal Perth Hospital

Locations

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Dobney Hypertension Centre

Perth, , Australia

Site Status

Countries

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Australia

Other Identifiers

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REG 15-021

Identifier Type: -

Identifier Source: org_study_id

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