Screening for pulmonary hypertension with the Eko CORE 500 digital stethoscope
Official title: Deep Learning for Algorithmic Detection of Pulmonary Hypertension Using a Combined Digital Stethoscope and Three-lead Electrocardiogram
Run by Eko Devices, Inc. · NCT07136623 · Data updated 2026-11-12
This project will test whether synchronized heart-sound and three-lead ECG recordings from the Eko CORE 500 can help detect pulmonary hypertension in adults undergoing a clinical echocardiogram or right-heart catheterization.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 1513 (estimated) |
| Sponsor | Eko Devices, Inc. Industry-sponsored |
| Locations | 2 sites (Los Angeles, California and 1 other locations) |
| Status | Recruiting |
| Started | August 1, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | May 31, 2027 |
| Registry record updated | August 24, 2026 |
| Trial ID | NCT07136623 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older who can consent and are scheduled for a clinically indicated transthoracic echocardiogram or right-heart catheterization within ±7 days are ideal candidates.
✕Probably not a fit
Patients who are currently hospitalized, unable to provide informed consent, or who have a limited/non-diagnostic echocardiogram are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, observational, multi-center project collects synchronized phonocardiogram (PCG) and three-lead ECG recordings using the FDA-cleared Eko CORE 500 from adults referred for clinically indicated transthoracic echocardiography (TTE) or right-heart catheterization (RHC). Trained staff obtain at least four 15-second recordings from standard aortic, pulmonic, tricuspid, and mitral auscultation sites during a single ~20-minute visit, and clinical TTE/RHC results within ±7 days provide reference labels. De-identified clinical data and, when available, clinical 12-lead ECGs may be abstracted for comparison. The primary goal is to develop and validate a software algorithm to detect pulmonary hypertension and, where possible, stratify its severity, with secondary analyses of diagnostic performance and subgroup generalizability.
Why it matters
Potential benefit: If successful, the approach could offer a quick, noninvasive screening tool to flag patients who may have pulmonary hypertension and need confirmatory testing.
How similar studies have gone: Acoustic and AI-based analyses have shown promise for detecting other cardiac conditions, but using synchronized PCG plus three-lead ECG specifically to screen for pulmonary hypertension is relatively novel and not yet widely validated.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
University of California Los Angeles
Los Angeles, California, United States Recruiting -
Duke University
Durham, North Carolina, United States Suspended
Study contacts
- Principal investigator: Michael Troy, MD — University of California, Los Angeles
- Study coordinator: Nicole Sutter, MPH
- Email: colie.sutter@ekohealth.com
- Phone: 707-280-7059
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.