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

Deep Learning for Detection of Pulmonary Hypertension and Reduced Left Ventricular Ejection Fraction Using a Combined Digital Stethoscope and Three-lead Electrocardiogram

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not stated
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Heart tracing (ECG)

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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%)."
  • "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."
  • "This prospective, observational study aims to determine whether acoustic heart sounds (phonocardiograms, PCG) and three-lead electrocardiograms (ECG) recorded with the Eko CORE 500 digital stethoscope can identify patients with PH or low EF (defined as EF ≤ 40%) when compared with echocardiographic or right heart catheterization findings as the reference standard."
  • "Participants will complete a single study visit, lasting approximately 20 minutes, during which heart sounds and three-lead ECG signals will be recorded at four standard auscultation sites (aortic, pulmonic, tricuspid, and mitral) while seated."
  • "If a participant has undergone a 12-lead ECG within 30 days of their echocardiogram or right heart catheterization, de-identified ECG data will also be included for comparison purposes."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether AI can use heart sounds and heart electrical signals from a digital stethoscope to find high blood pressure in the lung arteries or a heart that pumps weakly. It is for adults having a heart ultrasound or a right heart catheter test as part of their care outside the hospital. There is one study visit lasting about 20 minutes.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Able and willing to agree to join after learning about the study.
  • Have a heart ultrasound or right heart catheter test within 7 days before or after the study tests. A right heart catheter test uses a thin tube to measure pressure in the heart and lung arteries.

Who can't join

  • Unable or unwilling to agree to join after learning about the study.
  • Staying in a hospital.
  • Having only a limited heart ultrasound, which checks fewer parts of the heart. This rule does not apply if you are having a right heart catheter test.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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)

Study sites (4)

IL

VA