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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01029223
• Other study ID #: 141/07
• Status: Withdrawn
• Phase: Phase 4
• First received: December 7, 2009
• Last updated: November 7, 2011
• Start date: October 2008
• Est. completion date: December 2011

Study information

• Verified date: November 2011
• Source: Bayside Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 42
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Blood Pressure

Intervention

Drug:
• ivabradine

• metoprolol

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayside Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	central and peripheral arterial and pulse wave velocity		baseline, and 4 hours following the administration of placebo, metoprolol or ivabradine.	No
Secondary	Central pulse pressure		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.	No