Arrythmia, Diffuse Fibrosis, Focal Fibrosis, Heart Failure
Conditions
Keywords
Cardiovascular Magnetic Resonance Imaging, Tissue Characterisation, Wearable Technology, Prognosis, Response to Therapy
Brief summary
150 patients admitted to University Hospital Southampton with heart failure will undergo comprehensive Cardiovascular Magnetic Resonance (CMR) imagining during their admission and continuous heart rhythm monitoring using wearable technology post discharge. We hypothesise that analysis of this outcome data will discover novel CMR tissue characterisation and heart rhythm biomarkers that can be used to predict adverse clinical outcomes in heart failure populations and how individual patients will respond to specific therapies.
Detailed description
PREDICT-HF a low risk single centre observational study in which 150 consecutive patients admitted with a new, primary diagnosis of heart failure undergo advanced CMR to non-invasively establish their individual myocardial tissue characteristics during their initial presentation. All study participants 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 Samsung S-PATCH device. To enable multivariate statistical analysis to be performed each study participant will undergo a range of validated investigation 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. MACE, rehospitalisation, decompensation and arrhythmias will be meticulously recorded for each participant throughout the study period. This study will identify novel CMR derived tissue characterisation biomarkers of 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.
Interventions
None listed
Sponsors
University Hospital Southampton NHS Foundation Trust
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥18 * First hospital admission with a diagnosis of HF (as defined below) * Able and willing to provide informed consent * Able to undergo CMR
Exclusion criteria
* Known or subsequent diagnosis of amyloidosis, sarcoidosis or hypertrophic cardiomyopathy * Severe valve disease of any type requiring inpatient surgery * Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device * Clinically apparent myocardial ischemia which requires revascularisation * Myocardial infarction or revascularisation within the previous 60 days * Intra cardiac mass which requires surgery * Active endocarditis * Septicaemia * Pregnancy * Life expectancy \<2 years secondary to any other cause (i.e. malignancy) * Active treatment with chemotherapy * Severe renal failure (GFR \<30)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality | 2 years | Number of deaths within the study population |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rehospitalisation with heart failure | 2 years | Number of Rehospitalisations with heart failure within the study population |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cardiac arrythmia | 30 days | The number of any cardiac arrhythmia following discharge within the study population |
Countries
United Kingdom
Contacts
Primary ContactAndrew Flett, MBBS MD(Res) MRCP BSc(Hons)
Backup ContactRobert Adam, MBBS MRCP BSc(Hons)
Outcome results
None listed