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

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. Identifier: NCT01029223
Recruitment Status : Withdrawn
First Posted : December 9, 2009
Last Update Posted : November 9, 2011
Information provided by:
Bayside Health

Brief Summary:
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 or disease Intervention/treatment Phase
Blood Pressure Drug: ivabradine Drug: metoprolol Drug: placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
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
Study Start Date : October 2008
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Metoprolol
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ivabradine Drug: ivabradine
Experimental: metoprolol Drug: metoprolol
Placebo Comparator: placebo Drug: placebo

Primary Outcome Measures :
  1. 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 :
  1. 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. ]

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

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

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

Additional relevant MeSH terms:
Anti-Arrhythmia Agents
Antihypertensive Agents
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