Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope
NCT ID: NCT05873387
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2420 participants
OBSERVATIONAL
2023-07-12
2026-12-31
Brief Summary
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Detailed Description
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Patients with PH are classified into five groups based on the etiology and mechanism of the disease group.1 Group 1, also called pulmonary arterial hypertension (PAH), is associated with several other systemic diseases (e.g., connective tissue disease), genetic syndromes, or drugs. Whereas, group 2 is associated with left-sided heart disease. Group 3 is due to chronic lung disorders and hypoxemia. Group 4 is due to pulmonary artery obstructions and is the subtype found in patients with chronic thromboembolic pulmonary hypertension. Lastly, Group 5 is idiopathic PH or PH with unidentified mechanism.
PH is a major pathophysiological disorder that can involve multiple clinical conditions and can complicate most cardiovascular and respiratory diseases. PH is defined as an increase in mean pulmonary artery pressure (mPAP) \>20 mm Hg at rest, as assessed by right heart catheterization. Due to the invasive nature of right heart catheterization, echocardiography is an established non-invasive alternative diagnostic tool.
About 80% of all right heart catheterizations have evidence of elevated PA pressures (mPAP\> 19 mm HG) and \~60% have a mean PA pressure \> 25 mm Hg. Also, the prevalence of elevated PA pressure is \~ 50% on clinically indicated echocardiograms.5 Elevated PA pressure either by echocardiography or right heart catheterization is associated with increased mortality, hospitalizations and heart failure admissions.
However, since PH requires either echocardiogram or invasive catheterization, it remains underdiagnosed. Identification of a minimally invasive and rapid screening process for PH will help identify this at risk group in a primary care setting to target for further evaluation and aggressive risk factor modification. We hypothesize that combining phonocardiography (PCG) from heart auscultation with electrocardiography (ECG) may provide specific elements that correlate with PA pressures on echocardiogram and can help screen for the probability of pulmonary hypertension in a patient.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Echocardiography ground-truth
Subjects with ECG/PCG recordings labeled against echocardiography
Use of Eko DUO stethoscope (paired ECG/PCG)
Auscultation of heart sounds using electronic stethoscope
Right heart catheterization ground-truth
Subjects with ECG/PCG recordings labeled against right heart catheterization
Use of Eko DUO stethoscope (paired ECG/PCG)
Auscultation of heart sounds using electronic stethoscope
Interventions
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Use of Eko DUO stethoscope (paired ECG/PCG)
Auscultation of heart sounds using electronic stethoscope
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Intubated patients
18 Years
ALL
Yes
Sponsors
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Eko Devices, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Guarav Choudhary, MD
Role: PRINCIPAL_INVESTIGATOR
Lifespan
Locations
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Rhode Island Hospital
Providence, Rhode Island, United States
The Miriam Hospital
Providence, Rhode Island, United States
Providence VA Medical Center
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023.3
Identifier Type: -
Identifier Source: org_study_id
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