Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05873387 |
| Other study ID # |
2023.3 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 12, 2023 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
July 2023 |
| Source |
Eko Devices, Inc. |
| Contact |
Spencer Kieu |
| Phone |
714-623-6652 |
| Email |
spencer.kieu[@]ekohealth.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Pulmonary hypertension (PH) is a syndrome resulting from restricted flow through the
pulmonary circulation causing increased pulmonary vascular resistance and ultimately right
heart failure. There are several different subtypes of PH, however, all carry a poor
prognosis and often result in or hasten death. Multiple pathogenic pathways have been
implicated in the development of PH, including those at the molecular and genetic levels and
in the smooth muscle and endothelial cells and adventitia.
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.
