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).

Pfizer558 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

558

Conditions

ATTR-CM

Interventions

Machine learning algorithmOTHER

Software to calculate the predicted probability of ATTRwt-CM for these heart failure patients based on the presence and absence of certain features

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * HF patients (defined as having ≥1 claim for HF or HF treatment) ≥50 years old with clinical diagnosis of ATTRwt-CM or non-amyloid HF ascertained by charts. Patients will be required to have ≥12 months of continuous activity in the EHR or claims prior to the Index Date. Exclusion Criteria: * Patients with any of the following diagnoses: * Light chain (AL) amyloidosis * Intracranial hemorrhage * Cerebral amyloid angiopathy * End stage renal disease * Blood cancer

Locations (1)

Pfizer

New York, New York, United States

Outcomes

Primary Outcomes

Number of Participants According to Clinical Diagnosis Predicted Using the Machine Learning (ML) Algorithm

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.

Time frame: At diagnosis, anytime during retrospective data identification period of approximately 5.4 years; retrospective data observed in this study for approximately 2.5 months

Data from ClinicalTrials.gov

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