Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope
NCT ID: NCT07136623
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1513 participants
OBSERVATIONAL
2025-08-01
2026-08-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG
NCT07087613
Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope
NCT05873387
Improvement of an Algorithm to Detect Structural Heart Murmurs in Adult Patients Using Electronic Stethoscopes
NCT07202104
A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension
NCT07079592
Artificial Intelligence (AI) Analysis of Synchronized Phonocardiography (PCG) and Electrocardiogram(ECG)
NCT06009718
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Currently hospitalized at the time of study procedures.
If enrolled via TTE path: limited (non-diagnostic) echocardiogram.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eko Devices, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Michael Troy, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California Los Angeles
Los Angeles, California, United States
Duke University
Durham, North Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024.4
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.