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).

Completed

• Conditions: ATTR-CM
• Interventions: Other: Machine learning algorithm

• Registration Number: NCT06029452
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-01
• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Primary Completion: 2023-11-14
• Study Completion: 2023-11-14
• Status Verified: 2024-11
• Results First Submitted: 2024-11-07
• Results First Submitted QC: 2024-11-07
• Last Update Submitted: 2024-11-07
• Results First Posted: 2025-01-03
• Last Update Posted: 2025-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 558

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ATTRwt-CM and non-amyloid heart failure patients	Machine learning algorithm	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer; 🇺🇸 New York, New York, United States