Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope

NCT07136623 | Recruiting FDA Device

• 1 other identifier: 2024.4
• Study Type: observational
• Target: 1,513
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Pulmnary Hypertension

Keywords

pulmonary hypertension

Outcome Measures

Primary Outcomes (1)

• Area under the receiver operating characteristic (ROC) curve (AUC) for pulmonary hypertension (PH) detection

  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 Outcomes (1)

• Positive and negative predictive values for PH detection

  Study completion (up to 12 months); reference within ±7 days.

Study Arms (1)

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; Diagnostic Test: Eko CORE 500 three-lead electrocardiogram (ECG) recording

Interventions

Eko CORE 500 phonocardiogram (PCG) recording DIAGNOSTIC_TEST

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.

Also known as: Eko CORE 500

Outpatient Echo/RHC Patients

Eko CORE 500 three-lead electrocardiogram (ECG) recording DIAGNOSTIC_TEST

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.

Outpatient Echo/RHC Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Unwilling or unable to provide informed consent.
• Currently hospitalized at the time of study procedures.
• If enrolled via TTE path: limited (non-diagnostic) echocardiogram.

Sponsors & Collaborators

• Eko Devices, Inc.: lead

Study Sites (2)

University of California Los Angeles

Los Angeles, California, 90095, United States

RECRUITING

Duke University

Durham, North Carolina, 27708, United States

RECRUITING

Related Publications (7)

• Maron BA, Choudhary G, Khan UA, Jankowich MD, McChesney H, Ferrazzani SJ, Gaddam S, Sharma S, Opotowsky AR, Bhatt DL, Rocco TP, Aragam JR. Clinical profile and underdiagnosis of pulmonary hypertension in US veteran patients. Circ Heart Fail. 2013 Sep 1;6(5):906-12. doi: 10.1161/CIRCHEARTFAILURE.112.000091. Epub 2013 Jun 27.

  PMID: 23811965 BACKGROUND

• Choudhary G, Jankowich M, Wu WC. Elevated pulmonary artery systolic pressure predicts heart failure admissions in African Americans: Jackson Heart Study. Circ Heart Fail. 2014 Jul;7(4):558-64. doi: 10.1161/CIRCHEARTFAILURE.114.001366. Epub 2014 Jun 5.

  PMID: 24902739 BACKGROUND

• Strange G, Stewart S, Celermajer DS, Prior D, Scalia GM, Marwick TH, Gabbay E, Ilton M, Joseph M, Codde J, Playford D; NEDA Contributing Sites. Threshold of Pulmonary Hypertension Associated With Increased Mortality. J Am Coll Cardiol. 2019 Jun 4;73(21):2660-2672. doi: 10.1016/j.jacc.2019.03.482.

  PMID: 31146810 BACKGROUND

• Assad TR, Maron BA, Robbins IM, Xu M, Huang S, Harrell FE, Farber-Eger EH, Wells QS, Choudhary G, Hemnes AR, Brittain EL. Prognostic Effect and Longitudinal Hemodynamic Assessment of Borderline Pulmonary Hypertension. JAMA Cardiol. 2017 Dec 1;2(12):1361-1368. doi: 10.1001/jamacardio.2017.3882.

  PMID: 29071338 BACKGROUND

• Maron BA, Hess E, Maddox TM, Opotowsky AR, Tedford RJ, Lahm T, Joynt KE, Kass DJ, Stephens T, Stanislawski MA, Swenson ER, Goldstein RH, Leopold JA, Zamanian RT, Elwing JM, Plomondon ME, Grunwald GK, Baron AE, Rumsfeld JS, Choudhary G. Association of Borderline Pulmonary Hypertension With Mortality and Hospitalization in a Large Patient Cohort: Insights From the Veterans Affairs Clinical Assessment, Reporting, and Tracking Program. Circulation. 2016 Mar 29;133(13):1240-8. doi: 10.1161/CIRCULATIONAHA.115.020207. Epub 2016 Feb 12.

  PMID: 26873944 BACKGROUND

• Humbert M, Sitbon O, Chaouat A, Bertocchi M, Habib G, Gressin V, Yaici A, Weitzenblum E, Cordier JF, Chabot F, Dromer C, Pison C, Reynaud-Gaubert M, Haloun A, Laurent M, Hachulla E, Simonneau G. Pulmonary arterial hypertension in France: results from a national registry. Am J Respir Crit Care Med. 2006 May 1;173(9):1023-30. doi: 10.1164/rccm.200510-1668OC. Epub 2006 Feb 2.

  PMID: 16456139 BACKGROUND

• Frost A, Badesch D, Gibbs JSR, Gopalan D, Khanna D, Manes A, Oudiz R, Satoh T, Torres F, Torbicki A. Diagnosis of pulmonary hypertension. Eur Respir J. 2019 Jan 24;53(1):1801904. doi: 10.1183/13993003.01904-2018. Print 2019 Jan.

  PMID: 30545972 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Michael Troy, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Sutter, MPH

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: August 15, 2025
• First Posted: August 22, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)