NCT07113223 Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
| NCT ID | NCT07113223 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Idoven 1903 S.L. |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,968 participants |
| Start Date | 2025-07-23 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,968 participants in total. It began in 2025-07-23 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07113223 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07113223 currently recruiting?
Yes, NCT07113223 is actively recruiting participants. Contact the research team at juan.delgado@salud.madrid.org for enrollment information.
Where is the NCT07113223 trial being conducted?
This trial is being conducted at Madrid, Spain, Madrid, Spain, Madrid, Spain, Santander, Spain and 1 additional location.
Who is sponsoring the NCT07113223 clinical trial?
NCT07113223 is sponsored by Idoven 1903 S.L.. The trial plans to enroll 1,968 participants.
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