About this trial
Heart failure (HF) is a complex clinical syndrome associated with impaired heart function, poor quality of life for patients and high healthcare costs. Accurate risk stratification and early diagnosis in HF are challenging as signs and symptoms are non-specific. Here the investigators propose to address this global challenge by developing novel analytic methods for HF (STRATIFYHF). A prospective clinical study will collect patient-specific data related to medical history, a physical examination for signs and symptoms, blood tests including natriuretic peptides, an electrocardiogram (ECG), an echocardiogram (ultrasound of the heart), cardiovascular magnetic resonance imaging (MRI), demographic, socio-economic and lifestyle data along with novel technologies (cardiac output response to stress (CORS) test and voice recognition biomarkers) from individuals at-risk of developing HF and those with a confirmed diagnosis of HF. STRATIFYHF will use these data to develop, validate and implement the first artificial intelligence (AI)-based, Decision Support System (DSS) for assessing and predicting the risk of HF development, its early diagnosis and progression. STRATIFYHF will integrate 1) patient-specific data i.e. demographic, clinical, genetic, lifestyle and socio-economic, 2) an AI-based digital patient library and AI-driven algorithms for risk stratification, early diagnosis, and disease progression in HF, and 3) a highly innovative multifunctional AI-based DSS and mobile application for informing a patient-centred, personalised, prevention and treatment strategies for HF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals at risk of developing HF ≥45 years of age sub-divided into two categories based on current definitions i.e.,
All patients willing to visit the clinical research facility and able to provide written informed consent.
Patients with confirmed diagnosis of HF (heart failure reduced ejection fraction; heart failure mildly reduced ejection fraction; heart failure improved ejection fraction; and heart failure preserved ejection fraction) over the previous 24 months or
hospitalisation due to HF ≥45 years of age
Disqualifiers
inability to provide verbal informed consent
presenting with severe symptoms
major co-morbidity or other alternative diagnoses (e.g., malignancy, severe respiratory disease, mental health problem); recent acute coronary syndrome (within 60 days)
severe physical disability preventing independence
Trial population
The study population would include men and women suspected with heart failure who have been referred to secondary care for specialist review and have attended a heart failure diagnostic clinic.
Trial design
Cohort
Prospective
Treatments tested in this trial
Cardiac Output Response to Stress (CORS) test
Diagnostic testCardiac Output Response to Stress (CORS) is a novel, non-invasive, easy-to-use test developed by the Newcastle and Coventry Universities. CORS test measures heart function (cardiac output) at rest and in response to short step-exercise using validated electrical signal processing bioreactance technology, similar to an ECG.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy of the DSS
Collection of prospective data for the diagnostic accuracy (i.e., sensitivity and specificity) of the DSS to predict risk of developing HF within 12 months.
Secondary outcomes
Demographic and clinical predictors of risk, diagnosis, and progression of heart failure.
To identify demographic and clinical predictors of risk, diagnosis, and progression of heart failure.
Locations
Sponsors and contacts
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Coventry University
Lead sponsor
Newcastle University
Collaborator
University of Cambridge
Collaborator
University of Novi Sad
Collaborator
University of Florence
Collaborator
University of Regensburg
Collaborator
Utrecht University, Utrecht, the Netherlands.
Collaborator
Servicio Madrileño de Salud, Madrid, Spain
Collaborator
This trial is not recruiting at the moment. You can still explore other options: