An interventional study of EchoNet-LVH Assessment in Cardiac Amyloidosis, sponsored by Cedars-Sinai Medical Center. Enrolling by invitation at 4 sites in United States. Open to participants aged 22 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Diagnostic
Recent advances in machine learning and image processing techniques have shown that machine learning models can identify features unrecognized by human experts and accurately assess common measurements made in clinical practice. Echocardiography is the most common form of cardiac imaging and is routinely and frequently used for diagnosis. However, there is often subjectivity and heterogeneity in interpretation. Artificial intelligence (AI)'s ability for precision measurement and detection is important in both disease screening as well as diagnosis of cardiovascular disease.
Cardiac amyloidosis (CA) is a rare, underdiagnosed disease with targeted therapies that reduce morbidity and increase life expectancy. However, CA is frequently overlooked and confused with heart failure with preserved ejection fraction. Some estimates suggest that CA can be as prevalence as 1% in a general population, with even higher prevalence in patients with left ventricular hypertrophy, heart failure, and other cardiac symptoms that might prompt echocardiography.
AI guided disease screening workflows have been proposed for rare diseases such as cardiac amyloidosis and other diseases with relatively low prevalence but significant human impact with targeted therapies when detected early. This is an area particularly suitable for AI as there are multiple mimics where diseases like hypertrophic cardiomyopathy, cardiac amyloidosis, aortic stenosis, and other phenotypes might visually be similar but can be distinguished by AI algorithms. The investigators have developed an algorithm, termed EchoNet-LVH, to identify cardiac hypertrophy and identify patients who would benefit from additional screening for cardiac amyloidosis.
122 studies on the registry are indexed under Amyloid Neuropathies, Familial; 71 are open to participants now.
This study's planned enrollment of 500 is above the median of 60 across 61 interventional studies indexed under Amyloid Neuropathies, Familial.
Browse Amyloid Neuropathies, Familial studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Each potential participant identified by automated AI-enhanced echocardiogram review will be chart reviewed by each site's CA experts for appropriateness of enrollment and clinican suspicion for CA. Based on the judgement of CA experts, potential participants that meet eligibility criteria will be called to be consented, followed in the study, and referred to see the CA expert.
Diagnostic Test: EchoNet-LVH Assessment
The AI algorithm is previously described (Duffy et al. JAMA Cardiology 2022) and will remain unchanged throughout the course of the study. A pre-determined threshold based on prior experiments and analysis has been decided prior to the study. From each site, approximately 100,000 echocardiogram studies will be reviewed by EchoNet-LVH for approximately 500 patients to be flagged.
Positive Predictive Value
1. Among patients that screening positive and consented to the trial, the proportion of patients that subsequently are confirmed to have CA upon clinical follow-up. 2. Statistical Analysis: Fisher's exact (two-sided) for superiority Comparison with PPV of standard clinical suspicion (PPV of all comers that receive Tc-99m PYP/HDP imaging scan or other clinical diagnosis).
Time frame: 1 year
Time to Diagnosis from Echocardiogram Study to Clinical Diagnosis
Statistical Analysis: Cox proportional hazards test with comparison with of Study population vs. comparison with Patients with echocardiogram study showing at least moderate left ventricular hypertrophy by human interpretation.
Time frame: 1 year
Number of Patients that Receive Treatment for CA
Time frame: 1 year
Number of Cardiac Amyloidosis Diagnoses
Time frame: 1 year
Number of Participants with All Cause Death
Time frame: 1 year
Number of Participants with All Cause Hospitalization
Time frame: 1 year
Number of Participants with Heart Failure Hospitalization
defined as needing IV diuretics or BNP higher than baseline or ICD9/10 code
Time frame: 1 year
Plan to share: No
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Cedars-Sinai Medical Center