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NCT07136623 · ClinicalTrials.gov registry record
Detecting Pulmonary Hypertension With the Eko CORE 500 Digital Stethoscope
A clinical trial of Pulmnary Hypertension, sponsored by Eko Devices.
- Recruiting
- Registry status
- 1,513
- Enrollment target
- 2
- Study locations
NCT07136623: Recruiting study of Pulmnary Hypertension, sponsored by Eko Devices.
NCT07136623 is a study of Pulmnary Hypertension that is actively recruiting participants, run by Eko Devices. The registered enrollment target is 1,513 participants. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07136623, a study of Pulmnary Hypertension, is actively recruiting participants, sponsored by Eko Devices.
- RECRUITING
- Registry status
- 1,513 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
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.
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 |
What NCT07136623 shows while recruiting
NCT07136623 is an observational study that tracks outcomes without assigning an intervention. Its 1,513 participants enrollment target places it among the larger protocols in the corpus.
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.
NCT07136623 reports a single indexed study location in California, North Carolina.
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.
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).
Who is sponsoring clinical trial NCT07136623?
This trial is sponsored by Eko Devices, which has 16 total clinical trials registered on ClinicalTrials.gov.
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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