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RECRUITINGINTERVENTIONAL

Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)

Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms: a Pragmatic Randomized Clinical Trial (DECISION)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The DECISION trial aims to evaluate the efficacy of an artificial intelligence (AI)-powered system, Willem™, for improving the detection of heart failure (HF) in primary care settings by interpreting electrocardiograms (ECGs). The study seeks to answer whether AI-assisted ECG interpretation enhances diagnostic accuracy and clinical outcomes compared to standard ECG evaluation in patients with suspected HF or those at high risk. This multicenter, pragmatic, randomized clinical trial involves two groups: patients receiving AI-assisted ECG analysis and those undergoing standard ECG evaluation. The study's primary analysis will compare the diagnostic performance of AI-assisted ECG versus standard ECG using sensitivity, specificity, and predictive value metrics. Secondary analyses will evaluate healthcare resource utilization, clinical outcomes, and usability feedback from healthcare providers. Results will inform the potential integration of AI-assisted ECG in routine primary care workflows for earlier HF detection and better resource allocation.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients with Suspected HF (Group S): - Able to understand and accept the study constraints and to provide willing to sign a consent form (either themselves or a legal representative). - Age over 65 years (i.e., 65 included). - Presence of symptoms and/or signs typical of Heart Failure (defined by the European Society of Cardiology, ESC), including breathlessness (during activity or at rest, lying down, waking up at night needing to catch their breath), fatigue, swollen ankles/legs, and/or palpitations. - Patients at Risk of Heart Failure due to the presence of cardiovascular (Group R): - Able to understand and accept the study constraints and to provide willing to sign a consent form (either themselves or a legal representative). - Age over 65 years (i.e., 65 included). - Absence of symptoms and/or signs typical of Heart Failure (defined by the ESC), including breathlessness (during activity or at rest, lying down, waking up at night needing to catch their breath), fatigue, swollen ankles/legs, and/or palpitations. - Presence of at least 1 ACC/AHA Heart Failure risk factor, including hypertension, cardiovascular disease (atrial fibrillation, coronary heart disease or stroke), diabetes, obesity, exposure to cardiotoxic agents, genetic variant for cardiomyopathy, or family history of cardiomyopathy that requires an ECG test for any reason in a primary care center or with an indication of a regular health examination where an ECG is included. Who Should NOT Join This Trial: - Unwillingness or inability to sign the written willing to sign a consent form. - Previous Heart Failure diagnosis. - Unavailability or suboptimal quality ECG. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients with Suspected HF (Group S): * Able to understand and accept the study constraints and to provide informed consent (either themselves or a legal representative). * Age over 65 years (i.e., 65 included). * Presence of symptoms and/or signs typical of Heart Failure (defined by the European Society of Cardiology, ESC), including breathlessness (during activity or at rest, lying down, waking up at night needing to catch their breath), fatigue, swollen ankles/legs, and/or palpitations. * Patients at Risk of Heart Failure due to the presence of cardiovascular (Group R): * Able to understand and accept the study constraints and to provide informed consent (either themselves or a legal representative). * Age over 65 years (i.e., 65 included). * Absence of symptoms and/or signs typical of Heart Failure (defined by the ESC), including breathlessness (during activity or at rest, lying down, waking up at night needing to catch their breath), fatigue, swollen ankles/legs, and/or palpitations. * Presence of at least 1 ACC/AHA Heart Failure risk factor, including hypertension, cardiovascular disease (atrial fibrillation, coronary heart disease or stroke), diabetes, obesity, exposure to cardiotoxic agents, genetic variant for cardiomyopathy, or family history of cardiomyopathy that requires an ECG test for any reason in a primary care center or with an indication of a regular health examination where an ECG is included. Exclusion Criteria: * Unwillingness or inability to sign the written informed consent. * Previous Heart Failure diagnosis. * Unavailability or suboptimal quality ECG.

Treatments Being Tested

DEVICE

Willem™ platform ECG assessment

AI-assisted ECG analysis via the Willem™ platform

Locations (5)

Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Primary Care: Gerencia Asistencial Atención Primaria Madrid
Madrid, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Region Stockholm
Stockholm, Sweden