Skip to main content
OpenTrials
Completed

NCT Number: NCT06029452

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).

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

ATTR-CM

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

New York, 10018, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Machine learning algorithm

Other

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

Primary outcomes

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

    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

    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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Retrospective Chart Validation Study Evaluating the Performance of Machine Learning Algorithm (ML) to Predict the Clinical Diagnosis of Wild-type Transthyretin Amyloid Cardiomyopathy (ATTRwt-CM) and Non-amyloid Heart Failure Among Patients With Heart Failure (HF)

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Sep 8, 2023
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.