Status:

COMPLETED

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).

Lead Sponsor:

Pfizer

Conditions:

ATTR-CM

Eligibility:

All Genders

50+ years

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 di...

Eligibility Criteria

Inclusion

  • 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

  • Patients with any of the following diagnoses:
  • Light chain (AL) amyloidosis
  • Intracranial hemorrhage
  • Cerebral amyloid angiopathy
  • End stage renal disease
  • Blood cancer

Key Trial Info

Start Date :

September 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 14 2023

Estimated Enrollment :

558 Patients enrolled

Trial Details

Trial ID

NCT06029452

Start Date

September 1 2023

End Date

November 14 2023

Last Update

January 3 2025

Active Locations (1)

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1

Pfizer

New York, New York, United States, 10018

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). | DecenTrialz