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

NCT01029223 | Withdrawn Phase 4

• 1 other identifier: 141/07
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• central and peripheral arterial and pulse wave velocity

  baseline, and 4 hours following the administration of placebo, metoprolol or ivabradine.

Secondary Outcomes (1)

• 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.

Study Arms (3)

ivabradine

EXPERIMENTAL

Drug: ivabradine

metoprolol

EXPERIMENTAL

Drug: metoprolol

placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

ivabradine DRUG

ivabradine

metoprolol DRUG

metoprolol

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 - 25 years OR
• Aged \> 60 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayside Health: lead

MeSH Terms

Interventions

Ivabradine; Metoprolol

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 9, 2009
• Study Start: October 1, 2008
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 9, 2011

Record last verified: 2011-11