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

Recruiting now

Conditions studied: Hypertension, Pulmonary, Heart Failure With Reduced Ejection Fraction

In brief

This is a prospective, observational study evaluating whether heart sounds (phonocardiograms) and three-lead electrocardiograms (ECGs) recorded using the Eko CORE 500 digital stethoscope can help detect pulmonary hypertension (PH) and low left ventricular ejection fraction (EF ≤ 40%). PH is a condition characterized by high blood pressure in the pulmonary arteries, which can lead to heart failure and carries significant risks if undiagnosed. Low EF, which indicates reduced pumping ability of the heart, is also associated with increased risk of severe cardiac events but can remain undetected because patients often have no symptoms or only nonspecific symptoms. In this study, adults undergoing clinically indicated echocardiograms or right heart catheterization at outpatient sites will be invited to participate. Participants will complete a single study session lasting about 20 minutes, during which heart sounds and a three-lead ECG will be collected using the Eko CORE 500 device. If participants have had a clinical 12-lead ECG within 30 days of their echocardiogram or right heart catheterization, those data may also be used for analysis. A clinically indicated echocardiogram or right heart catheterization (RHC) performed within seven days before or after the Eko CORE 500 recording will serve as the reference standard to confirm the presence or absence of PH and low EF. Up to 3,850 participants may be enrolled across multiple sites to ensure that approximately 3,500 complete the study. The data collected will be used to develop and validate artificial intelligence (AI) algorithms that aim to detect PH and identify low EF, potentially enabling earlier and simpler screening for these conditions in clinical practice.

Key facts

Study ID

NCT07087613

Run by

Eko Devices, Inc.

People needed

3850

Starts

2025-06-15

Expected to finish

2027-05-31

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Prairie Cardiovascular — O'Fallon, Illinois, United States (enrolling)
• Prairie Education & Research Cooperative — Springfield, Illinois, United States (enrolling)
• St Johns Hospital, Springfield — Springfield, Illinois, United States (enrolling)
• Sentara Norfolk General Hospital — Norfolk, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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