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Effects of Heart Rate Reduction on Central Arterial Pressure in Healthy Individuals

Sponsor
Bayside Health (Other)
Overall Status
Terminated
CT.gov ID
NCT00825123
Collaborator
Baker Heart and Diabetes Institute (Other)
2
Enrollment
1
Location
3
Arms
37.2
Duration (Months)
0.1
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Actual Enrollment :
2 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 :
Oct 1, 2008
Actual Primary Completion Date :
Nov 8, 2011
Actual Study Completion Date :
Nov 8, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ivabradine

Drug: Ivabradine
Ivabradine 10 mg once
Other Names:
  • Coralan

    		•
    Active Comparator: Metoprolol

    Drug: Metoprolol
    Metoprolol 50 mg once
    Placebo Comparator: Placebo

    Drug: Placebo
    Lactose powder

    Outcome Measures

    Primary Outcome Measures

    1. central arterial pressure [baseline and 4 hours post treatment]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 The Alfred Hospital Melbourne Victoria Australia 3004

    Sponsors and Collaborators

    • Bayside Health
    • Baker Heart and Diabetes Institute

    Investigators

    • Principal Investigator: Bronwyn A Kingwell, PhD, Baker IDI Hearte & Diabetes Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bayside Health
    ClinicalTrials.gov Identifier:
    NCT00825123
    Other Study ID Numbers:
    • 141/07 bayside health
    First Posted:
    Jan 19, 2009
    Last Update Posted:
    Aug 17, 2020
    Last Verified:
    Nov 1, 2009
    Keywords provided by Bayside Health
    healthy individuals
    Additional relevant MeSH terms:
    Metoprolol

    Study Results

    No Results Posted as of Aug 17, 2020