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Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope
NCT07136623 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- DIAGNOSTIC_TEST Eko CORE 500 phonocardiogram (PCG) recording
- DIAGNOSTIC_TEST Eko CORE 500 three-lead electrocardiogram (ECG) recording
Study Locations (2)
California
- University of California Los Angeles — Los Angeles
North Carolina
- Duke University — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,513 participants |
| Start Date | 2025-08-01 |
| Est. Completion | 2026-08-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07136623
The ClinicalTrials.gov registry entry for NCT07136623 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,513 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eko Devices, which has 63 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pulmnary Hypertension appearing as the primary indexed condition, and to 2 interventions — of which Eko CORE 500 phonocardiogram (PCG) recording is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07136623 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07136623 about?
NCT07136623 is a clinical study titled "Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope". 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 pulmonar...
What is the current status of trial NCT07136623?
This trial is currently recruiting. The enrollment target is 1,513 participants. The study started on 2025-08-01. Estimated completion is 2026-08-01.
What conditions does trial NCT07136623 study?
This clinical trial studies the following conditions: Pulmnary Hypertension. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07136623?
The interventions under investigation include: Eko CORE 500 phonocardiogram (PCG) recording (DIAGNOSTIC_TEST), Eko CORE 500 three-lead electrocardiogram (ECG) recording (DIAGNOSTIC_TEST). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07136623?
This trial is sponsored by Eko Devices, which has 63 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07136623 being conducted?
This trial has 2 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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