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AI-Powered ECG could spot silent heart weakness before It's too late

NCT ID NCT05867407

Diagnosis Sponsor: Anumana, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested an artificial intelligence tool that analyzes a standard ECG (heart electrical test) to detect when the heart's main pumping chamber is weak. Over 11,000 adults in outpatient clinics were randomly assigned to have their doctors see the AI results or not. The goal was to see if the AI helped doctors diagnose low ejection fraction (a measure of heart function) more often. The trial was stopped early, so the full impact is unknown.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Anumana Low EF AI-ECG Algorithm (device)
What this could lead to
If it works, this AI could help doctors find hidden heart weakness sooner, leading to earlier treatment and better outcomes.
What could go wrong
The trial was terminated early, so results are limited. The AI only suggests a risk; doctors still need to confirm with other tests. It may not work in all patient groups.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

11,610 people

The number who actually took part.

Started

Jun 2024

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Males and females 18 years or older (including females who are pregnant, breastfeeding and/or lactating) * Digital ECG captured or available within site for ECG-AI analysis at point-of-care Exclusion Criteria: * Known history of LVEF ≤ 40% * Known history of systolic heart failure * Known history of heart failure with reduced ejection fraction * Opted out of electronic health record-based research

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ventricular ejection fraction

Contacts and locations

Locations

  • Duke Health

    Durham, North Carolina, 27710, United States

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

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