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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Recruitment Status : Withdrawn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
Sponsor:
Information provided by:
Bayside Health

Brief 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.


Condition or disease Intervention/treatment Phase
Central Arterial Pressure Drug: Ivabradine Drug: Metoprolol Drug: Placebo Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. central arterial pressure [ Time Frame: baseline and 4 hours post treatment ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

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


Locations
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Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Investigators
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Principal Investigator: Bronwyn A Kingwell, PhD Baker IDI Hearte & Diabetes Institute
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Responsible Party: A/Prof Bronwyn Kingwell, Bakere IDI Heart & Diabetes Institute
ClinicalTrials.gov Identifier: NCT00825123    
Other Study ID Numbers: 141/07 bayside health
First Posted: January 19, 2009    Key Record Dates
Last Update Posted: November 9, 2011
Last Verified: November 2009
Keywords provided by Bayside Health:
healthy individuals
Additional relevant MeSH terms:
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Metoprolol
Anti-Arrhythmia Agents
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