ivabradine & vascular function in patients with cardiovascular risk
Research type
Research Study
Full title
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.
IRAS ID
127610
Contact name
John Deanfield
Contact email
Sponsor organisation
Institut de Recherches Internationales Servier
Eudract number
2012-000215-89
Research summary
Abnormal endothelial function is a key early event in atherosclerosis (hardening of the arteries) which eventually leads to cardiovascular complications such as angina or heart attack.
Ivabradine is a drug that lowers heart rate (the number of times the heart beats per minute (bpm)). It is approved for the treatment of angina and heart failure in patients with an elevated heart rate. By reducing heart rate, Ivabradine has been shown to have a beneficial effect on the development and outcomes of cardiovascular disease, and one mechanism may be via improved endothelial function. High heart rate has been shown to be linked to abnormal endothelial function, due to the shear frictional stress on the walls of the blood vessels. Thus heart rate reduction with Ivabradine may improve endothelial function and reduce cardiovascular events.
This study will include 340 men and women, with risk factors for cardiovascular disease (high blood pressure, smokers, diabetes, high cholesterol) and a high resting heart rate of ≥ 75 bpm. They will be randomised to either ivabradine (175) or placebo (175) and we will assess if their endothelial function improves following treatment using an established non-invasive ultrasound scanning technique called Flow Mediated Dilatation (FMD). This measures the change in the diameter of an artery in the arm in response to blood flow. Patients will will make six visits over three months, with two measurements of FMD. This study is funded by Servier Research and Development Ltd.
REC name
London - Fulham Research Ethics Committee
REC reference
13/LO/1719
Date of REC Opinion
23 Dec 2013
REC opinion
Favourable Opinion