Effects of ivabradine on vascular function in individuals at increased risk of developing cardiovascular disease and with impaired endothelial functio
- Conditions
- Cardiovascular diseaseMedDRA version: 14.1Level: LLTClassification code 10007648Term: Cardiovascular disease, unspecifiedSystem Organ Class: 100000004849Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-000215-89-IT
- Lead Sponsor
- Institut de Recherches Internationales Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 340
- 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%)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 270
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70
- 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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the beneficial effect of ivabradine compared with placebo on endothelial function as measured by flow mediated dilation (FMD) of the brachial artery at 12 weeks of treatment;Secondary Objective: To investigate the effect of ivabradine compared with placebo on:<br>- biomarkers of endothelial function and cardiovascular risk,<br>- resting heart rate.<br>;Primary end point(s): Absolute percentage change in FMD of the brachial artery;Timepoint(s) of evaluation of this end point: At baseline and at the end of the study (W012)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): - Change in levels of biomarkers of endothelial function and cardiovascular risk<br>- Heart rate change;Timepoint(s) of evaluation of this end point: - At baseline and at the end of the study (W012) for the biomarkers<br>- From baseline to the end of the study for the heart rate