An observational study in Heart Failure With Reduced Ejection Fraction, sponsored by University Hospital Southampton NHS Foundation Trust. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2023-04-21.
Sponsored by University Hospital Southampton NHS Foundation Trust · Observational
A prospective, single centre, observational cohort study at University Hospital Southampton NHS Foundation Trust of 50 consecutive patients with Heart Failure with reduced Ejection Fraction and Ejection Fraction ≤35% who are eligible for sacubitril/valsartan (Entresto) initiation as per European Society of Cardiology guidelines.
Participants will have baseline and repeat cardiac magnetic resonance imaging (CMR) scans after 4-6 months of Entresto therapy. The CMR scans will be compared.
Clinical outcomes at 6 months including combined outcome of death and/or heart failure hospitalisation, KCCQ-12 questionnaire, 6-minute walk test, routine blood tests and NTproBNP will also be described.
This study will be the first to examine the effects of sacubitril/valsartan (Entresto) therapy on left ventricular reverse remodelling in patients with symptomatic HFrEF as demonstrated by Cardiac Magnetic Resonance Imaging.
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.
The 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.
The Investigators hypothesize that there will be an improvement in a variety of CMR parameters and the findings will help better understand the mechanisms by which this is achieved e.g. reduction in fibrosis (subtle scarring) of heart tissue. The Investigators also believe a proportion of patients will avoid the need for an ICD, due to improvement in heart function.
5,701 studies on the registry are indexed under Heart Failure; 1,219 are open to participants now.
This study's enrollment of 50 is below the median of 200 across 1,678 observational studies indexed under Heart Failure.
Browse Heart Failure studies →University Hospital Southampton NHS Foundation Trust is the lead sponsor of 147 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with symptomatic severe Heart Failure with reduced Ejection Fraction.
Exclusion Criteria:
Standard of care medical treatment with sacubitril/valsartan (Entresto). Additional Cardiac Magnetic Resonance Imaging (CMR) Scan after 4-6 months of treatment.
Left Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging
Left ventricular Volume quantified in (ml)
Time frame: 6 months
Indexed Left Ventricular Volume quantified on Cardiac Magnetic Resonance Imaging
Weight and Height will be combined to calculate Body Surface Area (m2). Left Ventricular Volume in (ml) will be divided by Body Surface Area to give indexed value (ml/m2)
Time frame: 6 months
Ejection Fraction quantified on Cardiac Magnetic Resonance Imaging
Ejection Fraction quoted in (%)
Time frame: 6 months
Cardiac Fibrosis quantification as measured by T1 mapping on Cardiac Magnetic Resonance Imaging
Time frame: 6 months
Strain Analysis as measured by feature tracking on Cardiac Magnetic Resonance Imaging
Time frame: 6 months
Combined outcome of death and/or heart failure hospitalisation
Time frame: 6 months
Quality of Life assessment: KCCQ-12 questionnaire
Kansas City Cardiomyopathy Questionnaire.
Time frame: 6 months
Quality of Life assessment: 6 Minute Walk Test
Distance walked (m) in 6 minutes
Time frame: 6 months
N-terminal pro B type natriuretic peptide (NTproBNP)
Blood Test
Time frame: 6 months
Plan to share: Undecided — TBC
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital Southampton NHS Foundation Trust