Detecting Pulmonary Hypertension with an Electronic Stethoscope

This study is looking at whether an electronic stethoscope, called the Eko DUO, can help doctors find pulmonary hypertension (PH). PH is a condition where blood pressure in the arteries leading to the lungs is too high. Researchers will collect heart sound recordings and electrical heart activity (ECG) from people using the Eko DUO stethoscope. These recordings will be compared to results from standard tests for PH, like echocardiograms and right heart catheterizations. The goal is to create a computer program that can use these stethoscope recordings to detect PH and see how severe it is. You might be able to join if you are over 18 and are having an echocardiogram or right heart catheterization. The study aims to enroll 2420 participants, but its current status is unclear.

Study design
This is an observational study, meaning participants will be monitored without receiving a specific treatment. The study plans to include 2420 participants.
What's involved
You would have your heart sounds listened to using the Eko DUO stethoscope. This would happen when you are already scheduled for an echocardiogram or right heart catheterization.
Compensation
Not stated in the trial record.
Follow-up
The study aims to build a database over up to 2 years and develop an algorithm over up to 3 years.

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NCT05873387

Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope

Recruiting
Not specifiedAges 18+Observational
Eko Devices, Inc.
~2,420 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Use of Eko DUO stethoscope (paired ECG/PCG)

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Build a database of matched ECG/PCG recordings labeled against RHCs and echocardiograms
Measured over Up to 2 years to complete database
+1 more outcome measured
Pulmonary Hypertension
3 sites across 1 states
Rhode Island3
  • Guarav Choudhary, MD · PRINCIPAL_INVESTIGATOR · Lifespan

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Eligibility criteria

Inclusion

Patients, ages \>18 years, referred for complete 2-dimensional echocardiography or right heart catheterization will be screened for inclusion.

Exclusion

Patients undergoing limited echocardiography
Intubated patients
  • Build a database of matched ECG/PCG recordings labeled against RHCs and echocardiogramsUp to 2 years to complete database

    Create a training/validation dataset composed of ECG/PCG recordings by enrolling at least 2200 subjects undergoing echocardiography and at least 220 subjects who have undergone right heart catheterization (RHC)

  • Develop and clinically test a deep learning algorithm that can detect PH and stratify its severityUp to 3 years to complete algorithm development

    Deliver an algorithm that detects PH with a sensitivity and specificity of ≥ 0.7