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AI-Enhanced ECG Screening for Cardiomyopathy

N/A
Waitlist Available
Led By Naveen Pereira, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Proband: Confirmed diagnosis of DCM with LVEF ≤ 45%
Proband: Must have at least one living ≥ 18 years first-degree relative
Must not have
Proband: Cardiomyopathy due to acute or reversible conditions
Proband: Moderate or greater primary valvular abnormality not due to underlying cardiomyopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if using a mobile ECG device to screen family members of individuals with Dilated Cardiomyopathy (DCM) can help detect heart issues. The ECG results will

Who is the study for?
This trial is for first-degree relatives (FDR) of individuals with dilated cardiomyopathy (DCM), aiming to detect early heart function issues using a mobile ECG device. Participants should be willing to use the device and transmit data for analysis.
What is being tested?
The study tests the KardiaRx ECG Screening's effectiveness in identifying reduced left ventricular ejection fraction, an indicator of potential heart problems, compared to standard care which includes screening with an echocardiogram.
What are the potential side effects?
Since this trial involves non-invasive ECG monitoring, there are minimal risks associated. Potential side effects may include discomfort or skin irritation from wearing the ECG device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with dilated cardiomyopathy and my heart's pumping efficiency is 45% or less.
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I have a living relative who is 18 or older and closely related to me.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My heart muscle disease was caused by a sudden or reversible condition.
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My heart valve issue is not caused by a heart muscle disease.
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I was born with a heart defect.
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I have severe high blood pressure that hasn't been treated or can't be treated.
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My low heart function is not due to pregnancy, inflammation, or exposure to toxins.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of First-Degree Relatives to complete the AI-ECG
Secondary study objectives
Number of subjects with an Left Ventricular Ejection Fraction ≤ 45%

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: First Degree RelativeExperimental Treatment1 Intervention
Subjects who are first-degree relatives of patients with DCM

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,337 Previous Clinical Trials
3,060,924 Total Patients Enrolled
5 Trials studying Cardiomyopathy
1,459 Patients Enrolled for Cardiomyopathy
Naveen Pereira, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
101 Total Patients Enrolled
~167 spots leftby Oct 2025