Evaluating Pulmonary Hypertension and Low Heart Pump Function Using a Digital Stethoscope and 3-Lead ECG

What this Trial Is About

Researchers are evaluating whether heart sounds and three-lead electrocardiograms recorded with the Eko CORE 500 digital stethoscope can help detect pulmonary hypertension PH and low left ventricular ejection fraction EF 40%. These are serious heart conditions that often go undiagnosed because they require special imaging tests like echocardiograms or invasive catheterization. This observational study aims to develop and validate artificial intelligence algorithms to identify these conditions earlier and more easily. Adults undergoing clinical echocardiograms or right heart catheterization at outpatient sites will participate in a single 20-minute study session. During this visit, heart sounds and three-lead ECGs will be recorded at four standard chest locations using the Eko CORE 500 device. If participants had a clinical 12-lead ECG within 30 days of their echocardiogram or catheterization, those results might also be included. The clinical echocardiogram or catheterization done within seven days before or after the recording will serve as the reference to confirm the presence or absence of PH and low EF. Participants will provide de-identified demographic and clinical data including medical history, lab results, and heart imaging measurements. Researchers will analyze the data to develop AI models assessing their accuracy in detecting PH and low EF based on sensitivity, specificity, and other diagnostic measures. The study plans to enroll up to 3,850 adults, with about 3,500 completing the study, to ensure robust results. Participants have only one study visit, and no results from the device or algorithms will be shared with them or added to medical records.

Deep Learning Detection of Pulmonary Hypertension and Low Ejection Fraction Via Digital Stethoscope and 3-Lead ECG