AI-powered ECG interpretation to detect heart failure in older primary care patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, pragmatic, randomized trial compares AI-assisted ECG interpretation using the Willem™ platform to standard ECG evaluation in primary care settings. Primary care centers are randomized to provide either the AI output to clinicians or usual ECG interpretation, with diagnostic confirmation by echocardiography and clinical follow-up. The primary analysis will compare sensitivity, specificity, and predictive values for heart failure detection, and secondary analyses will examine healthcare resource use, clinical outcomes, and provider usability feedback. The trial enrolls patients aged 65 and older who present with suspected heart failure or who are at elevated cardiovascular risk.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Juan Francisco Delgado Jiménez, MD, PhD
• Email: juan.delgado@salud.madrid.org
• Phone: +34917792640

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.