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This study has been withdrawn prior to enrollment.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:
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT01029223
First received: December 7, 2009
Last updated: November 7, 2011
Last verified: November 2011
  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: Double Blind (Subject, Caregiver, 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. ] [ Designated as safety issue: No ]

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. ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof Bronwyn Kingwell, Baker IDI Heart & Diabetes Institute
ClinicalTrials.gov Identifier: NCT01029223     History of Changes
Other Study ID Numbers: 141/07
Study First Received: December 7, 2009
Last Updated: November 7, 2011
Health Authority: Australia: Therapeutic Goods Administration

Additional relevant MeSH terms:
Metoprolol
Metoprolol succinate
Adrenergic Agents
Adrenergic Antagonists
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Autonomic Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sympatholytics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014