NCT07087613 Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG
| NCT ID | NCT07087613 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Eko Devices, Inc. |
| Condition | Hypertension, Pulmonary |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,850 participants |
| Start Date | 2025-06-15 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,850 participants in total. It began in 2025-06-15 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, observational study evaluating whether heart sounds (phonocardiograms) and three-lead electrocardiograms (ECGs) recorded using the Eko CORE 500 digital stethoscope can help detect pulmonary hypertension (PH) and low left ventricular ejection fraction (EF ≤ 40%). PH is a condition characterized by high blood pressure in the pulmonary arteries, which can lead to heart failure and carries significant risks if undiagnosed. Low EF, which indicates reduced pumping ability of the heart, is also associated with increased risk of severe cardiac events but can remain undetected because patients often have no symptoms or only nonspecific symptoms. In this study, adults undergoing clinically indicated echocardiograms or right heart catheterization at outpatient sites will be invited to participate. Participants will complete a single study session lasting about 20 minutes, during which heart sounds and a three-lead ECG will be collected using the Eko CORE 500 device. If participants have had a clinical 12-lead ECG within 30 days of their echocardiogram or right heart catheterization, those data may also be used for analysis. A clinically indicated echocardiogram or right heart catheterization (RHC) performed within seven days before or after the Eko CORE 500 recording will serve as the reference standard to confirm the presence or absence of PH and low EF. Up to 3,850 participants may be enrolled across multiple sites to ensure that approximately 3,500 complete the study. The data collected will be used to develop and validate artificial intelligence (AI) algorithms that aim to detect PH and identify low EF, potentially enabling earlier and simpler screening for these conditions in clinical practice.
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 years and older * Able and willing to provide informed consent * Completed a clinical echocardiogram or right heart catheterization within 7 days before or after study procedures Exclusion Criteria: * Unwilling or unable to provide informed consent * Patients who are hospitalized * Patients undergoing echocardiography with a limited echocardiogram (does not apply to patients undergoing right heart catheterization)
Contact & Investigator
Rose McDonough, MD
STUDY DIRECTOR
Senior Manager, Medical Affairs
Frequently Asked Questions
Who can join the NCT07087613 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypertension, Pulmonary. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07087613 currently recruiting?
Yes, NCT07087613 is actively recruiting participants. Contact the research team at colie.sutter@ekohealth.com for enrollment information.
Where is the NCT07087613 trial being conducted?
This trial is being conducted at O'Fallon, United States, Springfield, United States, Springfield, United States, Norfolk, United States.
Who is sponsoring the NCT07087613 clinical trial?
NCT07087613 is sponsored by Eko Devices, Inc.. The principal investigator is Rose McDonough, MD at Senior Manager, Medical Affairs. The trial plans to enroll 3,850 participants.