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This study has been withdrawn prior to enrollment.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:
Bayside Health
Information provided by:
Bayside Health
ClinicalTrials.gov Identifier:
NCT01029223
First received: December 7, 2009
Last updated: November 7, 2011
Last verified: November 2011
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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:
Drug Information available for:
Metoprolol
Metoprolol tartrate
Metoprolol succinate
Metoprolol fumarate
U.S. FDA Resources
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
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 Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions 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 |
ClinicalTrials.gov processed this record on May 16, 2013