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

NCT07087613 | Recruiting

• 1 other identifier: 2025.2
• Study Type: observational
• Target: 3,850
• Locations: 1 country
• Sites: 3

Brief Summary

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 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, those data may also be used for analysis. The echocardiogram performed as part of routine care 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.

Conditions

Hypertension, Pulmonary; Heart Failure With Reduced Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of the deep-learning algorithm for detecting pulmonary hypertension (PH)

  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. Sensitivity and specificity will be calculated by comparing algorithm predictions to the echocardiogram gold standard.

  Up to 12 months

Secondary Outcomes (1)

• Algorithm Diagnostic Performance for Detection of Low Ejection Fraction

  Through study completion, 1 year

Study Arms (1)

All Participants

Adults aged 18 years and older undergoing clinically indicated transthoracic echocardiography in an outpatient setting. Participants will have phonocardiogram (PCG) and 3-lead ECG recordings collected using the Eko CORE 500 digital stethoscope. Data will be used to develop and validate artificial intelligence algorithms to detect pulmonary hypertension and low left ventricular ejection fraction.

Device: Eko CORE 500 Digital Stethoscope

Interventions

Eko CORE 500 Digital Stethoscope DEVICE

The FDA-cleared Eko CORE 500 digital stethoscope is used to collect phonocardiogram (PCG) and three-lead ECG recordings from participants. This observational study uses these recordings to develop and validate artificial intelligence algorithms to detect pulmonary hypertension and low left ventricular ejection fraction. No modifications to the device or device functionality are being tested.

All Participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll adult patients (18 years and older) who are undergoing clinically indicated transthoracic echocardiography. Participants must be able and willing to provide informed consent and must complete a clinical echocardiogram within 7 days before or after the study procedures. Patients who are hospitalized, unable or unwilling to provide informed consent, or who are undergoing a limited echocardiogram will be excluded.

You may qualify if:

• Adults aged 18 years and older
• Able and willing to provide informed consent
• Completed a clinical echocardiogram 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

Sponsors & Collaborators

• Eko Devices, Inc.: lead

Study Sites (3)

Prairie Cardiovascular

O'Fallon, Illinois, 62269, United States

RECRUITING

Prairie Education & Research Cooperative

Springfield, Illinois, 62769, United States

RECRUITING

St Johns Hospital, Springfield

Springfield, Illinois, 62769, United States

RECRUITING

Related Publications (11)

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MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Rose McDonough, MD

  Senior Manager, Medical Affairs

  STUDY DIRECTOR

Central Study Contacts

Nicole Sutter

CONTACT

707-280-7059; colie.sutter@ekohealth.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: July 28, 2025
• Study Start: June 15, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)