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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04479813




Registration number
NCT04479813
Ethics application status
Date submitted
16/07/2020
Date registered
21/07/2020
Date last updated
29/09/2022

Titles & IDs
Public title
Role of Sympathetic Activation in Ischemia Reperfusion Injury
Scientific title
Role of Sympathetic Activation in Ischemia Reperfusion Injury
Secondary ID [1] 0 0
REG 15-021
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Sympathetic Nervous System Diseases 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Moxonidine 0.2 MG
Other interventions - placebo

Experimental: No conditioning + placebo - Participants will be given placebo to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.

Experimental: No conditioning + moxonidine - Participants will be given moxonidine to take orally 20 minutes prior to the first endothelial function measurement without conditioning tests.

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.

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.


Treatment: Drugs: 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 interventions: 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 code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
change in muscle sympathetic nerve activity
Timepoint [1] 0 0
1 day
Secondary outcome [1] 0 0
Endothelial Function using the EndoPat2000 device
Timepoint [1] 0 0
2 days

Eligibility
Key inclusion criteria
* healthy males, not on any medication, free of any history of metabolic, cardiovascular or cerebrovascular disease.
Minimum age
18 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* smoker

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Factorial
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2022
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Dobney Hypertension Centre - Perth
Recruitment postcode(s) [1] 0 0
- Perth

Funding & Sponsors
Primary sponsor type
Other
Name
Royal Perth Hospital
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/study/NCT04479813
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus Schlaich, MD,FAHA,FESC
Address 0 0
Royal Perth Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04479813