Effects of Heart Rate Reduction on Central Arterial Pressure in Healthy Individuals
NCT ID: NCT00825123
Last Updated: 2020-08-17
Study Results
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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TERMINATED
PHASE4
2 participants
INTERVENTIONAL
2008-10-31
2011-11-08
Brief Summary
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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.
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Detailed Description
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In order to assess each potential participant's suitability for the study based upon the relevant inclusion and exclusion criteria, the first visit will involve a medical consultation (history and physical examination), venepuncture (for full blood examination, lipid profile and biochemistry) and a 12-lead surface electrocardiogram. Baseline measurements of central and peripheral arterial and pulse wave velocity will be made at baseline, and 4 hours following the administration of either placebo, 50mg of metoprolol or a 10mg oral dose of ivabradine. The placebo will contain lactose powder.
Subjects will be randomized according to a 3-by-3 Latin square design. Central pulse pressure will be assessed using carotid artery tonometry using a non-invasive Millar Mikro-tip pressure transducer. The transducer is used to applanate the carotid artery and calibrated using brachial mean and diastolic blood pressure (automated oscillometric sphygmomanometer).
Pressure waveforms will also be recorded at the radial, brachial and femoral arteries to permit study of wave reflection at these sites.
Measurements will be taken be taken before and 4 hours following the oral administration of metoprolol/ivabradine/placebo.
Bias will be minimized by blinding both the participants and research staff responsible for data collection to the administered drug.
Any potential patient-specific confounding factors will have minimal impact, as the same participants will be studied after the administration of the three agents.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Ivabradine
Ivabradine
Ivabradine 10 mg once
Metoprolol
Metoprolol
Metoprolol 50 mg once
Placebo
Placebo
Lactose powder
Interventions
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Ivabradine
Ivabradine 10 mg once
Metoprolol
Metoprolol 50 mg once
Placebo
Lactose powder
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* aged 18 - 25 years OR
* aged \>60 years
Exclusion Criteria
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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Baker Heart and Diabetes Institute
OTHER
Bayside Health
OTHER_GOV
Responsible Party
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Principal Investigators
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Bronwyn A Kingwell, PhD
Role: PRINCIPAL_INVESTIGATOR
Baker IDI Hearte & Diabetes Institute
Locations
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The Alfred Hospital
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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141/07 bayside health
Identifier Type: -
Identifier Source: org_study_id
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