NCT06377319
Decision Support System for Diagnosis and Progression of Heart Failure
Not Yet Recruiting · Not specified · Coventry University · registry updated 2024-10-16
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- Inclusion criteria for patients at risk of heart failure:
- Individuals at risk of developing HF ≥45 years of age sub-divided into two categories based on current definitions i.e.,
- (i) patients with current or prior symptoms or signs of HF, but without structural, biomarker, or genetic markers of heart disease but have evidence of one of the following: hypertension, cardiovascular disease, type 2 diabetes mellitus, metabolic syndrome, known exposure to cardiotoxins and family history of cardiomyopathy and
- (ii) Patients with current or prior symptoms or signs of HF and have evidence of one of the following - structural heart disease (e.g. Left ventricular (LV) hypertrophy, chamber enlargement, wall motion abnormality, valvular disease), abnormal cardiac function (e.g., reduced LV or right ventricular systolic function, evidence of increased filling pressures or abnormal diastolic function), elevated natriuretic peptide or elevated cardiac troponin on exposure to a cardiotoxin.
- All patients willing to visit the clinical research facility and able to provide written informed consent.
- Inclusion criteria for patients with confirmed diagnosis of heart failure:
Exclusion
- Exclusion criteria for at-risk individuals and diagnosed heart failure patients:
- 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
- scheduled or implanted pacemaker or cardio-defibrillator in the last 3 months