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Sponsored by: |
Bayside Health |
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Information provided by: | Bayside Health |
ClinicalTrials.gov Identifier: | NCT00825123 |
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.
Condition | Intervention | Phase |
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Central Arterial Pressure |
Drug: Ivabradine Drug: Metoprolol Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment |
Official Title: | The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals |
Estimated Enrollment: | 40 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | December 2012 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Ivabradine: Experimental |
Drug: Ivabradine
Ivabradine 10 mg once
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Metoprolol: Active Comparator |
Drug: Metoprolol
Metoprolol 50 mg once
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Placebo: Placebo Comparator |
Drug: Placebo
Lactose powder
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Participants will undergo three days of laboratory testing, each visit separated by at least seven days.
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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy volunteers:
Exclusion Criteria:
Contact: Bronwyn A Kingwell, PhD | +61 8532 1518 | bronwyn.kingwell@bakeridi.edu.au |
Australia, Victoria | |
The Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3004 | |
Contact: Bronwyn A Kingwell, PhD +61385321518 bronwyn.kingwell@bakeridi.edu.au |
Principal Investigator: | Bronwyn A Kingwell, PhD | Baker IDI Hearte & Diabetes Institute |
Responsible Party: | Bakere IDI Heart & Diabetes Institute ( A/Prof Bronwyn Kingwell ) |
Study ID Numbers: | 141/07 bayside health |
Study First Received: | January 15, 2009 |
Last Updated: | January 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00825123 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
healthy individuals |
Neurotransmitter Agents Adrenergic Agents Metoprolol succinate Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents |
Cardiovascular Agents Anti-Arrhythmia Agents Healthy Antihypertensive Agents Metoprolol |
Neurotransmitter Agents Sympatholytics Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Cardiovascular Agents Metoprolol Antihypertensive Agents |
Pharmacologic Actions Autonomic Agents Therapeutic Uses Adrenergic beta-Antagonists Adrenergic Antagonists Peripheral Nervous System Agents Anti-Arrhythmia Agents |