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

August 13, 2020 updated by: Bayside Health

The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Lactose powder
Active Comparator: Metoprolol
Drug: Metoprolol
Metoprolol 50 mg once
Experimental: Ivabradine
Drug: Ivabradine
Ivabradine 10 mg once
Other Names:
  • Coralan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
central arterial pressure
Time Frame: baseline and 4 hours post treatment
baseline and 4 hours post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Collaborators

Baker Heart and Diabetes Institute

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

November 8, 2011

Study Completion (Actual)

November 8, 2011

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Actual)

August 17, 2020

Last Update Submitted That Met QC Criteria

August 13, 2020

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141/07 bayside health

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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