Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope (EKO-PH)

June 15, 2026 updated by: Eko Devices, Inc.

Deep Learning for Algorithmic Detection of Pulmonary Hypertension Using a Combined Digital Stethoscope and Three-lead Electrocardiogram

This prospective, observational study will evaluate whether synchronized heart sound (phonocardiogram, PCG) and three-lead electrocardiogram (ECG) recordings (entered as separate interventions in PRS, though collected together in practice) collected with the Eko CORE 500 can help screen for pulmonary hypertension (PH). Adults (≥18 years) undergoing clinically indicated transthoracic echocardiography (TTE) and/or right heart catheterization (RHC) will complete one study visit (~20 minutes). During the visit, study staff will obtain at least four 15-second CORE 500 recordings (aortic, pulmonic, tricuspid, and mitral areas). The clinical echocardiogram (and RHC, if performed) within ±7 days of the recordings will provide reference labels for the presence and severity of PH; de-identified demographic and clinical data may also be abstracted from the medical record.

The primary objective is to develop and validate a software algorithm to detect PH and, where possible, stratify severity using noninvasive PCG+ECG signals. These recordings are investigational data acquisitions for algorithm development only; they are not diagnostic procedures and will not be used for clinical decision-making. Primary performance measures are sensitivity and specificity versus echocardiogram and RHC references. No clinical decisions will be based on the investigational algorithm, and no changes to standard care are required. The study plans to enroll up to ~1,513 participants to obtain approximately 1,375 evaluable datasets across multiple outpatient sites.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, observational, multi-site study to determine whether synchronized heart-sound (phonocardiogram; PCG) and three-lead electrocardiogram (ECG) recordings (entered as separate interventions in PRS, though collected together in practice) collected with the FDA (U.S. Food and Drug Administration)-cleared Eko CORE 500 digital stethoscope can assist in screening for pulmonary hypertension (PH). Adults (≥18 years) referred for clinically indicated transthoracic echocardiography (TTE) and/or right heart catheterization (RHC) will complete a single study visit (~20 minutes). During the visit, trained staff will obtain at least four 15-second CORE 500 recordings from standard auscultation locations (aortic, pulmonic, tricuspid, and mitral).

The clinical TTE (and RHC, if performed) completed within ±7 days of the recordings will provide reference labels for the presence and severity of PH. If available, de-identified results from a clinical 12-lead ECG performed within 30 days of the TTE may also be abstracted for comparison. The primary objective is to develop and validate a software algorithm that detects PH from PCG+ECG signals; secondary objectives include assessing severity stratification and overall diagnostic performance (e.g., sensitivity/specificity, area under the receiver operating characteristic curve [AUC], positive predictive value [PPV], negative predictive value [NPV]), including subgroup analyses to evaluate generalizability. These recordings are investigational data acquisitions for algorithm development and detection research only; they are not diagnostic procedures and will not be used for clinical decision-making.

The study plans to enroll up to ~1,513 participants to obtain approximately 1,375 evaluable datasets (about 1,250 with TTE and 125 with RHC). No clinical decisions will be based on investigational algorithm outputs, and participation does not alter standard care. Key eligibility includes adults able to consent who have a clinical TTE or RHC within the protocol window; exclusions include current hospitalization and limited TTE studies. All study data are de-identified using site-maintained key-coded identification codes (IDs). PCG/ECG recordings are transmitted to a HIPAA (Health Insurance Portability and Accountability Act)-compliant, secure server; de-identified demographics, clinical data (e.g., TTE Doppler measures including TR [tricuspid regurgitation] velocity and estimated pulmonary artery systolic pressure, RHC hemodynamics), and relevant reports/images may be abstracted/uploaded per site procedures.

This minimal-risk study has IRB (Institutional Review Board) approval. No independent data monitoring committee is appointed; safety oversight is provided by site investigators with adverse event reporting per IRB policy. There is no cost to participants; modest compensation (≤$50, site-specific) may be provided. The CORE 500 hardware is FDA-cleared; however, the software algorithm evaluated in this study is investigational (not FDA-cleared). The aim is regulatory readiness for potential future submission without committing to a specific regulatory filing as part of this study.

Study Type

Observational

Enrollment (Estimated)

1513

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • University of California Los Angeles
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27708
        • Recruiting
        • Duke University
        • Principal Investigator:
          • Marat Fudim, MD, MHS
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Adults (≥18 years) receiving outpatient cardiovascular care at participating U.S. centers who are scheduled for, or have recently undergone, clinically indicated transthoracic echocardiography (TTE) and/or right heart catheterization (RHC) within ±7 days of the study visit. Participants are recruited consecutively from clinic and echo/RHC schedules; hospitalized patients are excluded. The population will include individuals with and without pulmonary hypertension across diverse demographics.

Description

Inclusion Criteria:

Age ≥ 18 years.

Able and willing to provide informed consent.

Clinically indicated transthoracic echocardiogram (TTE) or right heart catheterization (RHC) scheduled/performed within ±7 days of the study recording visit.

Exclusion Criteria:

Unwilling or unable to provide informed consent.

Currently hospitalized at the time of study procedures.

If enrolled via TTE path: limited (non-diagnostic) echocardiogram.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Outpatient Echo/RHC Patients

Outpatient Echo/RHC Patients

Adults (≥18) referred for clinically indicated transthoracic echocardiography (TTE) and/or right heart catheterization (RHC). One study visit (~20 minutes) to obtain ≥4 15-second Eko CORE 500 recordings (phonocardiogram and three-lead electrocardiogram) at standard auscultation sites. No randomization or changes to standard care; investigational algorithm outputs are not used clinically. TTE and/or RHC performed within ±7 days provide reference labels for presence/severity of pulmonary hypertension.
Diagnostic test: Eko CORE 500 phonocardiogram (PCG) recording
Noninvasive acquisition of heart sound (phonocardiogram, PCG) recordings using the FDA (U.S. Food and Drug Administration)-cleared Eko CORE 500 digital stethoscope. At least four 15-second recordings are collected at standard auscultation sites (aortic, pulmonic, tricuspid, mitral). Recordings are used solely for investigational algorithm development and are not used for diagnostic or clinical decision-making.
Other Names:
  • Eko CORE 500
Diagnostic test: Eko CORE 500 three-lead electrocardiogram (ECG) recording
Noninvasive acquisition of three-lead electrocardiogram (ECG) signals using the FDA-cleared Eko CORE 500 digital stethoscope. Recordings are obtained simultaneously with PCG at auscultation sites. Data are used solely for investigational algorithm development and are not intended for diagnostic use.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the receiver operating characteristic (ROC) curve (AUC) for pulmonary hypertension (PH) detection
Time Frame: Study completion (up to 12 months); reference within ±7 days.
Description: Area under the receiver operating characteristic (ROC) curve (AUC) of the phonocardiogram (PCG) + electrocardiogram (ECG) algorithm for classifying pulmonary hypertension (PH) vs. non-PH using probability outputs; reference is transthoracic echocardiography (TTE) and/or right heart catheterization (RHC) within ±7 days. 95% confidence intervals (CIs) reported.
Study completion (up to 12 months); reference within ±7 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and negative predictive values for PH detection
Time Frame: Study completion (up to 12 months); reference within ±7 days.
Positive predictive value (PPV) and negative predictive value (NPV) at a prespecified operating point; reference is transthoracic echocardiography (TTE) and/or right heart catheterization (RHC) within ±7 days. 95% confidence intervals (CIs) reported.
Study completion (up to 12 months); reference within ±7 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eko Devices, Inc.

Investigators

  • Principal Investigator: Michael Troy, MD, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2025

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

May 31, 2027

Study Registration Dates

First Submitted

August 15, 2025

First Submitted That Met QC Criteria

August 15, 2025

First Posted (Actual)

August 22, 2025

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share IPD due to consent limitations and proprietary algorithm development; aggregate results will be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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