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

Conditions

• Heart Failure With Reduced Ejection Fraction
• Hypertension, Pulmonary

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Jun 15, 2025

Status verified

Jul 2025

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

3,850 participants (estimated)

Arms

• Arm: 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.

Primary Outcome Measure

Sensitivity and specificity of the deep-learning algorithm for detecting pulmonary hypertension (PH) [ Time Frame: Up to 12 months ]

Central Contacts

• Nicole Sutter
  707-280-7059
  [email protected]

Locations (3)

Find similar trials in O'Fallon, IL

Related Studies

• A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
  PHASE3 · Enrolling By Invitation · United Therapeutics · Phoenix, Arizona
• Left vs Left Randomized Clinical Trial
  Recruiting · Baylor College of Medicine · Gilbert, Arizona
• Implementation and Interaction of Clinician And Patient-facing Tools Aiming to Intensify Neurohormonal Medicines for Heart Failure
  Recruiting · University of Colorado, Denver · Walnut Creek, California
• Study With Omecamtiv Mecarbil (CK-1827452) to Treat Chronic Heart Failure With Severely Reduced Ejection Fraction
  PHASE3 · Recruiting · Cytokinetics · Alexander City, Alabama