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

B

Bayside Health

Status and phase

Withdrawn
Phase 4

Conditions

Blood Pressure

Treatments

Drug: placebo
Drug: ivabradine
Drug: metoprolol

Study type

Interventional

Funder types

Other

Identifiers

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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