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
About this trial
This is an interventional treatment trial for Coronary Artery Disease
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
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
NCT ID
NCT02681978
First Posted
February 4, 2016
Last Updated
February 10, 2016
Sponsor
Campus Bio-Medico University
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