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

Bayside Health

Status and phase: Withdrawn; Phase 4

Conditions: Blood Pressure

Treatments: Drug: ivabradine; Drug: metoprolol; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01029223

141/07

Details and patient eligibility

About

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).

Enrollment: 42 estimated patients

Sex: Male

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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42 participants in 3 patient groups, including a placebo group

ivabradine

Experimental group

Treatment:

Drug: ivabradine

metoprolol

Experimental group

Treatment:

Drug: metoprolol

placebo

Placebo Comparator group

Treatment:

Drug: placebo