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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01029223
First Posted: December 9, 2009
Last Update Posted: November 9, 2011
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.
Information provided by:
Bayside Health
  Purpose
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).

Condition Intervention Phase
Blood Pressure Drug: ivabradine Drug: metoprolol Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 and peripheral arterial and pulse wave velocity [ Time Frame: baseline, and 4 hours following the administration of placebo, metoprolol or ivabradine. ]

Secondary Outcome 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. ]

Estimated Enrollment: 42
Study Start Date: October 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ivabradine Drug: ivabradine
Experimental: metoprolol Drug: metoprolol
Placebo Comparator: placebo Drug: placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Prof Bronwyn Kingwell, Baker IDI Heart & Diabetes Institute
ClinicalTrials.gov Identifier: NCT01029223     History of Changes
Other Study ID Numbers: 141/07
First Submitted: December 7, 2009
First Posted: December 9, 2009
Last Update Posted: November 9, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
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