ENVI:Effect of Entresto on Left Ventricular remodelling on Cardiac MRI
Research type
Research Study
Full title
Effect of Sacubitril/Valsartan (Entresto) on Left Ventricular reverse remodelling as demonstrated by Cardiac Magnetic Resonance (CMR) Imaging
IRAS ID
288602
Contact name
Andrew Flett
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The landmark trial PARADIGM-HF (2014) showed that a new drug Sacubitril/Valsartan (Entresto) was superior to a well-established drug (ACE-Inhibitors) for patients with severe heart failure. Entresto resulted in a 20% reduction in risk of death and hospitalisations, as well as improving quality of life and symptoms. This represented a major breakthrough in heart failure treatment and guidelines changed to recommend Entresto for patients in whom heart function had not improved on conventional heart failure drug treatments.
At the same point as recommending Entresto, international heart failure guidelines also recommend an Implantable Cardioverter-Defibrillator (ICD). An ICD is a device which can detect and treat potentially life-threatening heart rhythm abnormalities, which may occur in patients with persistently severe heart failure. The risk of complications associated with ICD implantation is not insignificant, up to 15%. Currently, there is a lack of consensus between clinicians regarding when best to offer ICD implantation in relation to Entresto treatment.
The exact mechanism of how Entresto achieves its beneficial effect is not fully understood. There are studies describing an improvement in heart function on Echocardiography (ultrasound). Some studies suggest a reduction in abnormal heart rhythms. There are however, no studies describing the effects of Entresto on heart tissue or function described on Cardiac Magnetic Resonance (CMR) Imaging. CMR is a specialised non-invasive scan which is excellent at looking at characteristics of heart tissue and is the gold standard for calculating heart function.
Our study will enrol 50 patients who have been referred for Entresto treatment. Participants will undergo a baseline CMR to evaluate heart characteristics and function before being started on Entresto. After 6 months, participants will receive another CMR and the two scans will be compared for differences in heart size, function and tissue characteristics.
We hypothesize that there will be an improvement in a variety of CMR parameters and the findings will help us better understand the mechanisms by which this is achieved e.g. reduction in fibrosis (subtle scarring) of heart tissue. We also believe a proportion of patients will avoid the need for an ICD, due to improvement in heart function.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0073
Date of REC Opinion
26 Mar 2021
REC opinion
Favourable Opinion