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Clinical Trials in Spain / NCT07113223
Recruiting Not applicable

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

NCT07113223 · tracked via the Priya Life Science Spain tracker
Sponsor
Idoven 1903 S.L
Phase
Not applicable
Started
2025-07-23
Last updated
2026-07-20

Condition(s) studied

Heart FailureCardiovascular Risk Factors

Investigational drug(s) / intervention(s)

Willem™ platform ECG assessment

Willem™ platform ECG assessment: AI-assisted ECG analysis via the Willem™ platform

Study summary

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.

Eligibility

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Device performance in patients with suspected Heart Failure — After performing the transthoracic echocardiography (TTE) in Visit 3 (7 days after screening)
    To compare the diagnostic performance of clinicians using a decision-aid system based on AI-assisted ECG vs. standard ECG in patients with suspected Heart Failure (symptoms and/or signs of Heart Failure) in the primary care setting analyzing the frequency of patients without cardiac pattern alterations in the ECG, ending up with diagnosis of absence of HF (using the NT-proBNP for stratification and eventually echocardiography when needed) 7 days after screening with the cardiology service.

Trial sites (5)

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

More Idoven 1903 S.L. trials in Spain

Multicenter Study for the Validation of an AI-based ECG Platform for Early Cardiac Amyloidosis Diagnosis Recruiting
Registry Study for the Evaluation of High-risk Cardiac Patients by WILLEM AI-based ECG Platform Recruiting
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM) Recruiting

Other trials for the same condition

Personalized Therapy Study - HFRS (TriageHF) Post Approval Study Active, not recruiting
Personalized Therapy Study - Attain Stability Quad Post-Approval Study Active, not recruiting
Effect of Acetazolamide on Diuresis and Natriuresis in Patients With Acute Heart Failure (SANDI STUDY) Recruiting
Phase III Study Investigating Heart Failure and Cardiovascular Death With Baxdrostat in Combination With Dapagliflozin Recruiting
A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Heart Failure Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07113223 on ClinicalTrials.gov ↗ ← All trials in Spain