Effects of Heart Rate Reduction on Central Arterial Pressure in Healthy Individuals
Information source: Bayside Health
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Central Arterial Pressure
Intervention: Ivabradine (Drug); Metoprolol (Drug); Placebo (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bayside Health Official(s) and/or principal investigator(s):
Bronwyn A Kingwell, PhD, Principal Investigator, Affiliation: Baker IDI Hearte & Diabetes Institute
Overall contact:
Bronwyn A Kingwell, PhD, Phone: +61 8532 1518, Email: bronwyn.kingwell@bakeridi.edu.au
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.
Clinical Details
Official title: The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
Primary outcome: central arterial pressure
Detailed description:
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
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Healthy volunteers:
- aged 18 - 25 years OR
- aged >60 years
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
Locations and Contacts
Bronwyn A Kingwell, PhD, Phone: +61 8532 1518, Email: bronwyn.kingwell@bakeridi.edu.au
The Alfred Hospital, Melbourne, Victoria 3004, Australia; Recruiting
Bronwyn A Kingwell, PhD, Phone: +61385321518, Email: bronwyn.kingwell@bakeridi.edu.au
Additional Information
Starting date: October 2008
Ending date: December 2012
Last updated: January 16, 2009
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