Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction

This study is looking at whether a digital stethoscope, the Eko CORE 500, can help detect two heart conditions: pulmonary hypertension (PH), which is high blood pressure in the lungs, and low left ventricular ejection fraction (EF ≤ 40%), which means your heart isn't pumping blood as effectively as it should. Both conditions can be serious if not found early. Researchers will use the Eko CORE 500 to record your heart sounds (phonocardiograms) and heart's electrical activity (three-lead ECG). These recordings will then be used to develop and test artificial intelligence programs that can identify PH and low EF. You can join if you are an adult aged 18 or older and have recently had or will soon have a heart ultrasound (echocardiogram) or a right heart catheterization. The main goal is to see how well these AI programs can detect PH.

Study design
This is an observational study aiming to enroll 3850 participants. It is not a randomized trial and does not involve a specific phase of drug development.
What's involved
You would have one study visit, lasting about 20 minutes, where heart sounds and a three-lead ECG will be recorded while you are seated.
Compensation
Not stated in the trial record.
Follow-up
The study will assess the detection of pulmonary hypertension for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07087613

Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG

Recruiting
Not specifiedAges 18+Observational
Eko Devices, Inc.
~3,850 participants
Updated 2026-06-18 on ClinicalTrials.gov
What's tested:Eko CORE 500 Digital Stethoscope

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and specificity of the deep-learning algorithm for detecting pulmonary hypertension (PH)
Measured over Up to 24 months
Hypertension, Pulmonary
Heart Failure With Reduced Ejection Fraction
4 sites across 2 states
Illinois3
Virginia1
  • Rose McDonough, MD · STUDY_DIRECTOR · Senior Manager, Medical Affairs

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Adults aged 18 years and older
Able and willing to provide informed consent
Completed a clinical echocardiogram or right heart catheterization within 7 days before or after study procedures

Exclusion

Unwilling or unable to provide informed consent
Patients who are hospitalized
Patients undergoing echocardiography with a limited echocardiogram (does not apply to patients undergoing right heart catheterization)
  • Sensitivity and specificity of the deep-learning algorithm for detecting pulmonary hypertension (PH)Up to 24 months

    The primary outcome is the diagnostic performance of the algorithm developed from Eko CORE 500 recordings to detect pulmonary hypertension, as confirmed by clinical echocardiography or right heart catheterization. Sensitivity and specificity will be calculated by comparing algorithm predictions to the echocardiogram or right heart catheterization gold standard.