Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00825123




Registration number
NCT00825123
Ethics application status
Date submitted
15/01/2009
Date registered
19/01/2009
Date last updated
17/08/2020

Titles & IDs
Public title
Effects of Heart Rate Reduction on Central Arterial Pressure in Healthy Individuals
Scientific title
The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals
Secondary ID [1] 0 0
141/07 bayside health
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Central Arterial Pressure 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ivabradine
Treatment: Drugs - Metoprolol
Treatment: Drugs - Placebo

Experimental: Ivabradine -

Active comparator: Metoprolol -

Placebo comparator: Placebo -


Treatment: Drugs: Ivabradine
Ivabradine 10 mg once

Treatment: Drugs: Metoprolol
Metoprolol 50 mg once

Treatment: Drugs: Placebo
Lactose powder
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
central arterial pressure
Timepoint [1] 0 0
baseline and 4 hours post treatment

Eligibility
Key inclusion criteria
Healthy volunteers:

* aged 18 - 25 years OR
* aged >60 years
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Chronic disease
* Unable to give informed consent
* Treated or untreated systemic arterial hypertension (SBP >160mmHg and/or DBP > 90mmHg)
* Resting bradycardia (heart rate < 60 beats/minute)
* Pregnancy or active lactation

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
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
8/11/2011
Sample size
Target
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Government body
Name
Bayside Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Baker Heart and Diabetes Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this project is to determine the effects of slowing heart rate upon both central and peripheral blood pressures using Ivabradine. The effects of Ivabradine will be compared to Metoprolol and placebo.

Participants will attend the hospital for 3 visits where they will be randomised to receive either Ivabradine, Metoprolol and placebo on each visit. Non-invasive measures of blood pressure will be recorded before and after consuming the study drug.
Trial website
https://clinicaltrials.gov/study/NCT00825123
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bronwyn A Kingwell, PhD
Address 0 0
Baker IDI Hearte & Diabetes Institute
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/NCT00825123