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Effects of Heart Rate Reduction on Central Arterial Pressure in Healthy Individuals
This study has been withdrawn prior to enrollment.

First Received on January 15, 2009.   Last Updated on November 7, 2011   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Bayside Health:

Primary Outcome Measures:
  • central arterial pressure [ Time Frame: baseline and 4 hours post treatment ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825123

Locations
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Bayside Health
Investigators
Principal Investigator: Bronwyn A Kingwell, PhD Baker IDI Hearte & Diabetes Institute
  More Information

No publications provided

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

Keywords provided by Bayside Health:
healthy individuals

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 09, 2012