Effects of ivabradine on vascular function in individuals at increased risk of developing cardiovascular disease and with impaired endothelial function;An international, multicentre, randomised, double-blind, placebo-controlled study over 12 weeks.
- Conditions
- impaired endothelial function10003216
- Registration Number
- NL-OMON40596
- Lead Sponsor
- Servier R&D Benelux
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
- Men or postmenopausal women of any ethnic origin aged between 21 and 74 years
- In sinus rhythm with resting HR at least 75 bpm
- At increased risk of subsequent cardiovascular disease (documented by the presence of at least two cardiovascular risk factors such as diabetes, hypertension, smoking, hypercholesterolemia) and impaired FMD * 5.0 %
- Previous diagnosis of coronary heart disease
- Previous diagnosis of heart failure or current clinical signs or symptoms in keeping with a diagnosis of heart failure
- History of cerebrovascular or peripheral arterial disease
- Uncontrolled hypertension
- Chronic infectious or inflammatory disease
- Chronic Obstructive Pulmonary Disease (COPD) treated with inhaled bronchodilators
- Malignancy
- Current therapy with nicorandil, nitrate, insulin
- Contra-indication to ivabradine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Absolute change from baseline over 12 week treatment period in FMD of the<br /><br>brachial artery</p><br>
- Secondary Outcome Measures
Name Time Method <p>Biomarkers of endothelial function and cardiovascular risk : change from<br /><br>baseline over 12 week treatment period in each biomarker.<br /><br>Resting heart rate (bpm) from 12 lead ECG : change from baseline over 12 week<br /><br>treatment period</p><br>