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).

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

558 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2023-11-14

Brief Summary

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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.

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Detailed Description

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Conditions

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ATTR-CM

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ATTRwt-CM and non-amyloid heart failure patients

Machine learning algorithm

Intervention Type OTHER

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

Interventions

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Machine learning algorithm

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No