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).

Sponsor

Pfizer (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT06029452

Collaborator

(none)

844

Enrollment

Location

1.9

Anticipated Duration (Months)

435.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
ATTR-CM	Other: Machine learning algorithm

Study Design

Study Type:

Observational

Anticipated Enrollment :

844 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official 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)

Anticipated Study Start Date :

Sep 2, 2023

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
ATTRwt-CM and non-amyloid heart failure patients	Other: 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

Arm

Intervention/Treatment

ATTRwt-CM and non-amyloid heart failure patients

Other: 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

Outcome Measures

Primary Outcome Measures

The total number of clinically diagnosed patients using the ML algorithm [60 days]
to evaluate the performance of the ATTRwt-CM ML model to predict the clinical diagnosis of ATTRwt-CM among HF patients against chart-review-based ground truth with a prespecified performance thresholds in sensitivity and specificity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer	New York	New York	United States	10018

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Pfizer

ClinicalTrials.gov Identifier:

NCT06029452

Other Study ID Numbers:

B3461111

First Posted:

Sep 8, 2023

Last Update Posted:

Sep 8, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Pfizer

Chronic Heart Failure

Additional relevant MeSH terms:

Heart Failure

Cardiomyopathies

Study Results

No Results Posted as of Sep 8, 2023