NCT04479813

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2015

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

6.7 years

First QC Date

July 16, 2020

Last Update Submit

September 28, 2022

Conditions

Central Sympathetic Nervous System Diseases

Keywords

Ischemiare-perfusionRemote conditioning

Outcome Measures

Primary Outcomes (1)

  • change in muscle sympathetic nerve activity

    Muscle sympathetic nerve activity assessed by microneurography

    1 day

Secondary Outcomes (1)

  • Endothelial Function using the EndoPat2000 device

    2 days

Study Arms (4)

No conditioning + placebo

EXPERIMENTAL

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

Other: placebo

No conditioning + moxonidine

EXPERIMENTAL

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

Remote pre-conditioning + placebo

EXPERIMENTAL

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

Other: placebo

Remote pre-conditioning + moxonidine

EXPERIMENTAL

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

Interventions

Moxonidine 0.2 MGDRUG

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 + moxonidineRemote pre-conditioning + moxonidine
placeboOTHER

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 + placeboRemote pre-conditioning + placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Details50 healthy male volunteers (25 aged 18-30 years and 25 aged 60-75 years)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • smoker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dobney Hypertension Centre

Perth, Australia

Location

MeSH Terms

Conditions

Ischemia

Interventions

moxonidine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Markus Schlaich, MD,FAHA,FESC

    Royal Perth Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

July 8, 2015

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

September 29, 2022

Record last verified: 2022-09

Locations

AU(1)