Decision Support System for Diagnosis and Progression of Heart Failure

ConditionHeart Failure
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45+
SponsorCoventry University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Cardiac Output Response to Stress (CORS) test

    Diagnostic test

    Cardiac 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

1,600 Participants
are divided into 2 treatment groups
Group A: Patients at risk of developing heart failure1 intervention
Group B: Patients diagnosed with heart failure1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: