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| Sponsor: | Bayside Health |
|---|---|
| Information provided by: | Bayside Health |
| ClinicalTrials.gov Identifier: | NCT00825123 |
Purpose
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 |
|---|---|---|
|
Central Arterial Pressure |
Drug: Ivabradine Drug: Metoprolol Drug: Placebo |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Basic Science |
| 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 |
|---|---|
| Experimental: Ivabradine |
Drug: Ivabradine
Ivabradine 10 mg once
Other Name: Coralan
|
| Active Comparator: Metoprolol |
Drug: Metoprolol
Metoprolol 50 mg once
|
| Placebo Comparator: Placebo |
Drug: Placebo
Lactose powder
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy volunteers:
Exclusion Criteria:
Contacts and Locations| Australia, Victoria | |
| The Alfred Hospital | |
| Melbourne, Victoria, Australia, 3004 | |
| Principal Investigator: | Bronwyn A Kingwell, PhD | Baker IDI Hearte & Diabetes Institute |
More Information
| Responsible Party: | A/Prof Bronwyn Kingwell, Bakere IDI Heart & Diabetes Institute |
| ClinicalTrials.gov Identifier: | NCT00825123 History of Changes |
| Other Study ID Numbers: | 141/07 bayside health |
| Study First Received: | January 15, 2009 |
| Last Updated: | November 7, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
healthy individuals |
|
Metoprolol Metoprolol succinate Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Antihypertensive Agents Sympatholytics Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Adrenergic beta-1 Receptor Antagonists Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |