The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals
Overview[ - collapse ][ - ]
| 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 | Blood Pressure |
| Intervention | Drug: ivabradine Drug: metoprolol Drug: placebo |
| Phase | Phase 4 |
| Sponsor | Bayside Health |
| Responsible Party | Bayside Health |
| ClinicalTrials.gov Identifier | NCT01029223 |
| First Received | December 7, 2009 |
| Last Updated | November 7, 2011 |
| Last verified | November 2011 |
Tracking Information[ + expand ][ + ]
| First Received Date | December 7, 2009 |
|---|---|
| Last Updated Date | November 7, 2011 |
| Start Date | October 2008 |
| Estimated Primary Completion Date | December 2011 |
| Current 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] |
| Current 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] |
Descriptive Information[ + expand ][ + ]
| Brief Title | The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals |
|---|---|
| Official Title | The Influence of Heart Rate Reduction Upon Central Arterial Pressure in Younger and Older Healthy Individuals |
| 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). |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 4 |
| Study Design | Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science |
| Condition | Blood Pressure |
| Intervention | Drug: ivabradine Drug: metoprolol Drug: placebo |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Withdrawn |
|---|---|
| Estimated Enrollment | 42 |
| Estimated Completion Date | December 2011 |
| Estimated Primary Completion Date | December 2011 |
| Eligibility 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 |
| Gender | Male |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01029223 |
|---|---|
| Other Study ID Numbers | 141/07 |
| Has Data Monitoring Committee | No |
| Information Provided By | Bayside Health |
| Study Sponsor | Bayside Health |
| Collaborators | Not Provided |
| Investigators | Not Provided |
| Verification Date | November 2011 |