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

NCT07113223 | Recruiting

• 2 other identifiers: 24/062230225
• Study Type: interventional
• Target: 1,968
• Locations: 2 countries
• Sites: 5

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.

Conditions

Heart Failure; Cardiovascular Risk Factors

Keywords

Heart Failure; Artificial Intelligence; Electrocardiogram (ECG); Primary Care; Diagnostic Tools; Cardiology; Electrocardiography; Risk Stratification

Outcome Measures

Primary Outcomes (1)

• Device performance in patients with suspected Heart Failure

  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.

  After performing the transthoracic echocardiography (TTE) in Visit 3 (7 days after screening)

Secondary Outcomes (2)

• Device performance in patients at cardiovascular risk but without Heart Failure symptoms

  After performing the transthoracic echocardiography (TTE) in Visit 3 (7 days after screening)

• Device performance at 6 months after ECG

  Six months after the ECG was performed

Study Arms (2)

Experimental

EXPERIMENTAL

AI-assisted ECG analysis via the Willem™ platform

Device: Willem™ platform ECG assessment

Comparator

NO INTERVENTION

Standard ECG assessment

Interventions

Willem™ platform ECG assessment DEVICE

AI-assisted ECG analysis via the Willem™ platform

Experimental

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Unwillingness or inability to sign the written informed consent.
• Previous Heart Failure diagnosis.
• Unavailability or suboptimal quality ECG.

Sponsors & Collaborators

• Idoven 1903 S.L.: lead
• Instituto de Investigación Marqués de Valdecilla: collaborator
• Karolinska Institutet: collaborator
• Region Stockholm: collaborator
• AstraZeneca: collaborator
• Servicio Madrileno De Salud (SERMAS): collaborator
• Fundación para la Investigación Biomédica del Hospital 12 de Octubre: collaborator
• Fundación para la Investigación Biomédica del Hospital Gregorio Maranon: collaborator
• Fundación para la Investigación e Innovación Biosanitaria de Atención Primaria de la Comunidad de Madrid (FIIBAP): collaborator

Study Sites (5)

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

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Juan Francisco Delgado Jiménez, MD, PhD

CONTACT

+34917792640; juan.delgado@salud.madrid.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, randomized, two-arm parallel-group, controlled trial

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 8, 2025
• Study Start: July 23, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: From the time of publication and for 5 years thereafter.
• Access Criteria: Upon request of investigators whose proposed research has received EC/IRB approval and after data use agreement.

Locations

ES (4); SE (1)