Development of an Algorithm to Detect Pulmonary Hypertension Using an Electronic Stethoscope
Deep Learning for Algorithmic Detection of Pulmonary Hypertension Using a Combined Digital Stethoscope and Single-lead Electrocardiogram
1 other identifier
observational
2,420
1 country
3
Brief Summary
The major goal of the study is to determine whether phonocardiography (using the Eko DUO stethoscope which can capture a three lead ECG reading) can present features that relate to the presence of PH diagnosed by echocardiography or right heart catheterization (RHC), and therefore have a potential to assist the provider to suspect PH.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2023
CompletedFirst Posted
Study publicly available on registry
May 24, 2023
CompletedStudy Start
First participant enrolled
July 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
January 21, 2026
January 1, 2026
3.4 years
May 16, 2023
January 18, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Build a database of matched ECG/PCG recordings labeled against RHCs and echocardiograms
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)
Up to 2 years to complete database
Develop and clinically test a deep learning algorithm that can detect PH and stratify its severity
Deliver an algorithm that detects PH with a sensitivity and specificity of ≥ 0.7
Up to 3 years to complete algorithm development
Study Arms (2)
Echocardiography ground-truth
Subjects with ECG/PCG recordings labeled against echocardiography
Right heart catheterization ground-truth
Subjects with ECG/PCG recordings labeled against right heart catheterization
Interventions
Auscultation of heart sounds using electronic stethoscope
Eligibility Criteria
Patients will be enrolled from Miriam and Rhode Island Hospital and Cardiovascular Institute outpatient locations where echocardiography or right heart catheterizations are performed. Approximately 40% of the patients enrolled will have a confirmed diagnosis of pulmonary hypertension.
You may not qualify if:
- Patients undergoing limited echocardiography
- Intubated patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Providence VA Medical Center
Providence, Rhode Island, 02908, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guarav Choudhary, MD
Lifespan
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2023
First Posted
May 24, 2023
Study Start
July 12, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share