Smartphone ECG with AI could spot hidden heart disease in families
NCT ID NCT06609174
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
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119 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Sep 2025
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
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