search
Back to results

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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ivabradine
Standard medical therapy
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Campus Bio-Medico University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Ivabradine group

Control group

Arm Description

Ivabradine 5 mg twice daily + standard medical therapy

Standard medical therapy

Outcomes

Primary Outcome Measures

Flow-mediated dilation of the brachial artery

Secondary Outcome Measures

Number of patients with flow-mediated dilation of the brachial artery <7%
Endothelium-independent dilation of the brachial artery
Dilation of the brachial artery after administration of 0.5 mg sublingual nitroglycerin
Correlation between heart rate and flow-mediated dilation of the brachial artery

Full Information

First Posted
February 4, 2016
Last Updated
February 10, 2016
Sponsor
Campus Bio-Medico University
search

1. Study Identification

Unique Protocol Identification Number
NCT02681978
Brief Title
Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease
Acronym
RIVENDEL
Official Title
Heart Rate Reduction by IVabradine for Improvement of ENDothELial Function in Patients With Coronary Artery Disease: the RIVENDEL Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivabradine group
Arm Type
Active Comparator
Arm Description
Ivabradine 5 mg twice daily + standard medical therapy
Arm Title
Control group
Arm Type
Other
Arm Description
Standard medical therapy
Intervention Type
Drug
Intervention Name(s)
Ivabradine
Intervention Description
Ivabradine 5 mg twice daily
Intervention Type
Drug
Intervention Name(s)
Standard medical therapy
Intervention Description
Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
Primary Outcome Measure Information:
Title
Flow-mediated dilation of the brachial artery
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Number of patients with flow-mediated dilation of the brachial artery <7%
Time Frame
8 weeks
Title
Endothelium-independent dilation of the brachial artery
Description
Dilation of the brachial artery after administration of 0.5 mg sublingual nitroglycerin
Time Frame
8 weeks
Title
Correlation between heart rate and flow-mediated dilation of the brachial artery
Time Frame
8 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Mangiacapra, MD, PhD
Organizational Affiliation
Campus Bio-Medico University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campus Bio-Medico University
City
Rome
State/Province
RM
ZIP/Postal Code
00128
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27520989
Citation
Mangiacapra F, Colaiori I, Ricottini E, Balducci F, Creta A, Demartini C, Minotti G, Di Sciascio G. Heart Rate reduction by IVabradine for improvement of ENDothELial function in patients with coronary artery disease: the RIVENDEL study. Clin Res Cardiol. 2017 Jan;106(1):69-75. doi: 10.1007/s00392-016-1024-7. Epub 2016 Aug 12.
Results Reference
derived

Learn more about this trial

Ivabradine to Improve Endothelial Function in Patients With Coronary Artery Disease

We'll reach out to this number within 24 hrs