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

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The purpose of this study is to determine the effect of slowing heart rate upon both central and peripheral blood pressures using a medication called Ivabradine which slows heart rate without affecting heart contraction, and to compare the effects of ivabradine to a traditional blood pressure lowering medication called metoprolol (which is a beta-blocker)...

Brief Summary

Official Title: “The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals”

The purpose of this study is to determine the effect of slowing heart rate upon both central and peripheral blood pressures using a medication called Ivabradine which slows heart rate without affecting heart contraction, and to compare the effects of ivabradine to a traditional blood pressure lowering medication called metoprolol (which is a beta-blocker).

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
  • Study Primary Completion Date: December 2011

Intervention(s) in this Clinical Trial

  • Drug: ivabradine
  • Drug: metoprolol
  • Drug: placebo

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: ivabradine
  • Experimental: metoprolol
  • Placebo Comparator: placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • central and peripheral arterial and pulse wave velocity
    • Time Frame: baseline, and 4 hours following the administration of placebo, metoprolol or ivabradine.
      Safety Issue?: No

Secondary Measures

  • Central pulse pressure
    • Time Frame: 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, metoprolol or ivabradine.
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Aged 18 - 25 years OR
  • Aged > 60 years

Exclusion Criteria

  • Chronic disease
  • Unable to give informed consent
  • Treated or untreated systemic arterial hypertension (SBP > 160 mmHg and/or DBP > 90 mmHg)
  • Resting bradycardia (heart rate < 60 beats/minute)
  • Pregnancy or active lactation

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Bayside Health Other

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01029223

Study ID Number: 141/07

ClinicalTrials.gov Identifier: NCT01029223

Health Authority: Australia: Therapeutic Goods Administration

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01029223