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).

Pfizer

Status: Completed

Conditions: ATTR-CM

Treatments: Other: Machine learning algorithm

Study type: Observational

Funder types: Industry

Identifiers

NCT06029452

B3461111

Details and patient eligibility

About

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.

Enrollment: 558 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

558 participants in 1 patient group

ATTRwt-CM and non-amyloid heart failure patients

Treatment:

Other: Machine learning algorithm