Heart Rate Reduction by IVabradine for Improvement of ENDothELial Function in Patients With Coronary Artery Disease: the RIVENDEL Study

Campus Bio-Medico University1 site in 1 country70 target enrollmentFebruary 2014

ConditionsCoronary Artery Disease

InterventionsIvabradine Standard medical therapy

DrugsIvabradine Standard medical therapy

Overview

Phase: Phase 4
Intervention: Ivabradine
Conditions: Coronary Artery Disease
Sponsor: Campus Bio-Medico University
Enrollment: 70
Locations: 1
Primary Endpoint: Flow-mediated dilation of the brachial artery
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study evaluates the effect of ivabradine on endothelial function in patients with coronary artery disease (CAD) after complete revascularization with percutaneous coronary angioplasty (PCI). At least 30 days after PCI, patients will be randomized to receive ivabradine 5 mg twice daily or to continue with standard medical therapy.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

July 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Campus Bio-Medico University

Responsible Party

Principal Investigator

Germano Di Sciascio

Prof. Germano Di Sciascio

Campus Bio-Medico University

Eligibility Criteria

Inclusion Criteria

•history of stable coronary disease
•complete coronary revascularization with PCI at least 1 month prior to recruitment
•sinus rhythm
•absence of anginal symptoms

Exclusion Criteria

•resting heart rate \<60 beats per minute
•severe reduction of left ventricle ejection fraction (\<40%)
•coronary artery by-pass surgery
•myocardial infarction, stroke or cerebral transient ischemic attack within the previous 6 months
•implanted pacemaker, cardioverter, or defibrillator
•sick sinus syndrome
•sinoatrial block
•congenital long QT
•complete atrioventricular block

Arms & Interventions

Ivabradine group

Ivabradine 5 mg twice daily + standard medical therapy

Intervention: Ivabradine

Ivabradine group

Ivabradine 5 mg twice daily + standard medical therapy

Intervention: Standard medical therapy

Control group

Standard medical therapy

Intervention: Standard medical therapy

Outcomes

Primary Outcomes

Flow-mediated dilation of the brachial artery

Time Frame: 8 weeks

Secondary Outcomes

Number of patients with flow-mediated dilation of the brachial artery <7%(8 weeks)
Endothelium-independent dilation of the brachial artery(8 weeks)
Correlation between heart rate and flow-mediated dilation of the brachial artery(8 weeks)