Effects of Heart Rate Reduction on Central Arterial Pressure in Healthy Individuals
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00825123|
Recruitment Status : Withdrawn
First Posted : January 19, 2009
Last Update Posted : November 9, 2011
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 or disease||Intervention/treatment||Phase|
|Central Arterial Pressure||Drug: Ivabradine Drug: Metoprolol Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals|
|Study Start Date :||October 2008|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2012|
Ivabradine 10 mg once
Other Name: Coralan
|Active Comparator: Metoprolol||
Metoprolol 50 mg once
|Placebo Comparator: Placebo||
- central arterial pressure [ Time Frame: baseline and 4 hours post treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00825123
|The Alfred Hospital|
|Melbourne, Victoria, Australia, 3004|
|Principal Investigator:||Bronwyn A Kingwell, PhD||Baker IDI Hearte & Diabetes Institute|