Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease (RIVENDEL)

February 10, 2016 updated by: Germano Di Sciascio, Campus Bio-Medico University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • RM
      • Rome, RM, Italy, 00128
        • Campus Bio-Medico University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ivabradine group
Ivabradine 5 mg twice daily + standard medical therapy
Drug: Ivabradine
Ivabradine 5 mg twice daily
Drug: Standard medical therapy
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Other: Control group
Standard medical therapy
Drug: Standard medical therapy
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Flow-mediated dilation of the brachial artery
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with flow-mediated dilation of the brachial artery <7%
Time Frame: 8 weeks
8 weeks
Endothelium-independent dilation of the brachial artery
Time Frame: 8 weeks
Dilation of the brachial artery after administration of 0.5 mg sublingual nitroglycerin
8 weeks
Correlation between heart rate and flow-mediated dilation of the brachial artery
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Investigators

  • Principal Investigator: Fabio Mangiacapra, MD, PhD, Campus Bio-Medico University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

February 4, 2016

First Submitted That Met QC Criteria

February 10, 2016

First Posted (Estimate)

February 15, 2016

Study Record Updates

Last Update Posted (Estimate)

February 15, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIVENDEL

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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