A Retrospective Validation Study To Identify Chart-Based Clinical Diagnosis Of Wild-Type Transthyretin Amyloid Cardiomyopathy (Attrwt-CM) And Non-Amyloid Heart Failure Among Patients With Heart Failure (HF).
CompletedResults postedLast updated 3 January 2025
What this trial tests
trial testing Machine learning algorithm in ATTR-CM in 558 participants. Completed in 14 November 2023.
50 and older, any sex, with ATTR-CM. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants According to Clinical Diagnosis Predicted Using the Machine Learning (ML) AlgorithmPrimary· At diagnosis, anytime during retrospective data identification period of approximately 5.4 years; retrospective data observed in this study for approximately 2.5 months
In this outcome measure number of participants were reported according to clinical diagnosis predicted by ML algorithm. True positive (TP) = participants with actual and predicted diagnosis of ATTRwt-CM; False positive (FP) = participants with actual diagnosis of non-amyloid HF and predicted diagnosis of ATTRwt-CM; False negative (FN) = participants with actual diagnosis of ATTRwt-CM and predicted diagnosis of non-amyloid HF; True negative (TN) = participants with actual and predicted diagnosis of non-amyloid HF.
Predicted for ATTRwt-CM
Group
Value
95% CI
ATTRwt-CM Participants
203
Non-amyloid HF Participants
133
Predicted for Non-amyloid HF
Group
Value
95% CI
ATTRwt-CM Participants
35
Non-amyloid HF Participants
187
Sponsor's own description
This is an observational, retrospective non-inferiority study with a study sample from a large national database.
A machine learning (ML) model will use a national database to predict the clinical diagnosis of ATTRwt-CM among HF patients. This study will include HF patients ≥50 years old.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Pfizer
Last refreshed: 3 January 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06029452.