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Tests treatment safety and results for Heart Failure
Official title Determining Efficacy of an Artificial Intelligence-based System for Heart Failure Detection Through Interpretation of Electrocardiograms (DECISION)
ClinicalTrials.gov ID: NCT07113223
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join 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...
- Patients at Risk of Heart Failure due to the presence of cardiovascular (Group R):
You likely can't join if
- Unwillingness or inability to sign the written informed consent.
- Previous Heart Failure diagnosis.
- Unavailability or suboptimal quality ECG.
See the full eligibility 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...
- 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...
- 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...
- Unwillingness or inability to sign the written informed consent.
- Previous Heart Failure diagnosis.
- Unavailability or suboptimal quality ECG.
The study team makes the final eligibility decision.
Where it's taking place
- Madrid, Spain
- Santander, Spain
- Stockholm, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Madrid, Spain; Santander, Spain; Stockholm, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.