PREDICT HF
Research type
Research Study
Full title
Using cardiovascular magnetic resonance tissue characterisation and wearable technology to predict clinical outcomes, response to therapy and arrhythmias in hospitalised heart failure patients - PREDICT HF
IRAS ID
241841
Contact name
Andrew Flett
Contact email
Sponsor organisation
University Hospital Southampton
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Heart failure is a common, complex syndrome with significant effects on quality of life, high risk of hospitalisation and high mortality rates. Current management guidelines improve clinical outcomes, but there are no accurate methods to predict response to therapy nor which patients benefit the most from advanced therapies.
We propose a low risk single centre observational study in which 150 consecutive patients admitted with a new, primary diagnosis of heart failure undergo advanced cardiovascular magnetic resonance imaging (CMR) to non-invasively establish their individual myocardial tissue characteristics during their initial presentation.
All patients recruited to the study will be invited to participate in an optional heart rhythm and rate monitoring sub study which will involve continuous electrocardiographic monitoring for up to 2 days prior to discharge and up to 30 day immediately post discharge using a non-invasive Samsung wearable S-PATCH heart monitoring device.
To enable multivariate statistical analysis to be performed each study participant will undergo several validated non-invasive investigations to comprehensively establish and monitor other recognised heart failure prognostic biomarkers.
Participants will be managed per current NICE heart failure guidelines and will undergo rigorous clinical reviews at 6, 12 and 24 months. All clinically relevant event data e.g. arrhythmias, rehospitalisation, decompensation and MACE will be meticulously recorded for each participant throughout the study period.
This study will be the first to identify novel CMR derived tissue characterisation biomarkers that correlate increased risk adverse outcome, response to therapy and arrhythmias in a hospitalised heart failure population. It will also be the first study to utilise wearable heart monitoring technology to accurately record heart rate and rhythm data in this population and investigate the potential impact of this on patient’s clinical management and outcomes.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0506
Date of REC Opinion
12 Apr 2018
REC opinion
Further Information Favourable Opinion