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Smartphone ECG with AI could spot hidden heart disease in families

NCT ID NCT06609174

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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study tested whether a portable 6-lead ECG device, paired with an artificial intelligence algorithm, can help screen first-degree relatives of people with dilated cardiomyopathy (a weakened heart muscle). The goal was to see if this mobile approach could detect reduced heart function early. The study enrolled 119 participants and measured how many relatives completed the screening and how many had a low ejection fraction (≤45%).

What this could mean

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

Active substance
KardiaRx 6-lead ECG device with AI interpretation
What this could lead to
If successful, this approach could make it easier and more accessible to screen at-risk family members for early signs of heart muscle disease.
What could go wrong
This is a small pilot study with only 119 participants, so results may not apply to everyone. The AI algorithm's accuracy in detecting reduced heart function needs further validation.

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

119 people

The number who actually took part.

Started

Oct 2024

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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 (Proband) * Male or female age ≥ 18 years * Confirmed diagnosis of DCM determined at the discretion of the treating physician and defined as LVEF ≤ 45% at any time during the clinical course of the patient * Must have at least one living ≥ 18 years FDR * Able to provide informed consent Inclusion Criteria (FDR) * Male or female age ≥ 18 years who are first-degree relatives of patients with DCM * Proband has provided informed consent * FDR able to provide informed consent * Access to a smartphone or digital tablet with cellular data or Wi-Fi access Exclusion Criteria (Proband) * DCM attributed to any other secondary form of cardiomyopathy per the investigator's determination * Proband has previously informed FDR to undergo cardiac screening * Ischemic cause of reduced LVEF * evidence of myocardial infarction, inducible ischemia or chest pain on stress testing in absence of coronary angiogram to rule out ischemic disease * history of acute coronary syndromes (STEMI, NSTEMI or unstable angina) revascularization or ≥75% stenosis of either left main or LAD or ≥75% stenosis of 2 major epicardial vessels on angiogram * Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy * Congenital structural heart disease * Severe and untreated or untreatable hypertension * Cardiomyopathy due to acute or reversible conditions; examples include tachyarrhythmias, thyroid disorders, iron overload * Any secondary cause of reduced LVEF such as pregnancy, myocarditis, amyloidosis, sarcoidosis, exposure to toxins including alcohol, substance abuse or chemotherapeutic drug * (CPC Participants only) Home address outside of traveling range Exclusion Criteria (FDR) * Previously informed about cardiac screening or has completed cardiac screening by TTE * Previously diagnosed with reduced LVEF * (CPC Participants only) Home address outside of traveling range

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

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