MedDataX Logo

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

NCT ID: NCT01029223

Last Updated: 2011-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Pressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ivabradine

Group Type EXPERIMENTAL

ivabradine

Intervention Type DRUG

metoprolol

Group Type EXPERIMENTAL

metoprolol

Intervention Type DRUG

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ivabradine

Intervention Type DRUG

metoprolol

Intervention Type DRUG

placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bayside Health

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Baker IDI Heart & Diabetes Institute

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

141/07

Identifier Type: -

Identifier Source: org_study_id