RECOVER-LV
Research type
Research Study
Full title
The effects of sacubitril/valsartan compared to valsartan on left ventricular remodelling in patients with asymptomatic left ventricular systolic dysfunction after myocardial infarction: a randomised, double-blinded, active-comparator, cardiac-MR based trial.
IRAS ID
196627
Contact name
John JV McMurray
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Eudract number
2017-003460-13
Duration of Study in the UK
2 years, 7 months, 1 days
Research summary
Research Summary
Hearts attacks are a common health problem in the United Kingdom. A proportion of people who survive heart attacks sustain damage to their heart muscle. This means that the heart does not pump blood around the body as efficiently as it should and can, over time, lead to symptoms such as breathlessness, fluid retention and reduced exercise capacity. This is known as heart failure. The development of heart failure also increases the risk of death in the years following a heart attack.
Our study proposes to compare a new medication (sacubitril/valsartan) to usual treatment in 100 patients with evidence of muscle damage after a heart attack to prevent the development of heart failure. This medication stops the body breaking down proteins which may help protect the heart muscle. Patients will take this medication for 12 months alongside the usual medications following a heart attack. The effect of the medication will be assessed using a magnetic resonance imaging (MRI) scanner (at the start of the trial and at 12 months) to look at the heart muscle and the pump function in detail along with measuring bloods tests which are markers of heart muscle damage. The study will be carried out in a large teaching hospital, Queen Elizabeth University Hospital, Glasgow.
We aim to show that sacubitril/valsartan is better than the current standard of care, valsartan, at slowing the decline in heart muscle contraction and increase in heart chamber size that may occur in patients with heart muscle damage following a heart attack. If we show that sacubitril/valsartan is more effective at reducing heart muscle damage in patients after a heart attack, our findings may lead to a larger randomised trial to see whether it or a similar drug can reduce the risk of developing heart failure after a heart attack (and improve survival).
Summary of Results
The aim of our study was to see if a medication called sacubitril/valsartan which stops the body breaking down proteins which help protect heart muscle, was better than the current standard of care, valsartan, at slowing the decline in heart muscle contraction and increase in heart chamber size that may occur in patients with heart muscle damage following a heart attack. We measured heart chamber size and function using MRI scanners. We recruited 93 patients to our study, and they were randomly allocated to one of the two treatments (sacubitril/valsartan or valsartan) for a period of 12 months in addition to their usual treatment.
After 12 months of treatment, we did not see any significant difference in heart chamber size or function between the two groups. In addition, blood tests of heart muscle wall stress and injury were not significantly reduced with sacubitril/valsartan compared with valsartan.
These results suggest that sacubitril/valsartan is no better than valsartan at preventing an increase in heart chamber size or a decline in heart function in patients who have heart muscle damage as a result of a previous heart attack and have not developed heart failure.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0128
Date of REC Opinion
10 Oct 2017
REC opinion
Further Information Favourable Opinion