Ivabradine in heart failure with preserved ejection fraction
Research type
Research Study
Full title
Effect of ivabradine versus placebo on cardiac function, exercise capacity, and neuroendocrine activation in patients with Chronic Heart Failure with Preserved left ventricular Ejection Fraction An 8-month, randomised double-blind, placebo controlled, international, multicentre study.
IRAS ID
122988
Contact name
John Cleland
Contact email
Sponsor organisation
Servier Research & Development Ltd
Eudract number
2012-002742-20
Research summary
The aim of this study is to investigate if a drug called ivabradine can help to improve heart function and the ability to exercise in patients with a type of chronic heart failure, called diastolic heart failure or Heart Failure with Preserved Ejection Fraction (HF-PEF) (sometimes described as having a stiff heart).
Ivabradine is currently approved for use in patients with angina and a type of heart failure called systolic heart failure. (In this type of heart failure the heart isn’t able to pump efficiently). This will be the first time ivabradine has been used in patients with HF-PEF.
Ivabradine works by lowering the heart rate i.e. the number of times the heart beats per minute (bpm). This allows more time for the heart to fill with blood and for the heart muscle to receive more oxygen. Ivabradine can only be used in patients with a high resting heart rate.
We think that ivabradine may also help patients with HF-PEF. To properly test this we need to compare HF-PEF patients treated with ivabradine to HF-PEF patients treated with a dummy or placebo, to see if there is any difference in how the heart functions. We will look at heart function in detail using ECHO, we will also measure any changes in how far a patient can walk in 6 minutes and also look at markers in the blood that indicate how the heart is functioning. These assesments will be made at selection into the study and will be compared after 8 months of treatment with ivabradine or placebo.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
13/YH/0140
Date of REC Opinion
12 Jun 2013
REC opinion
Further Information Favourable Opinion