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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).

NCT06029452

CompletedN/A

Sponsor: Pfizer

Conditions: ATTR-CM

Interventions: Machine learning algorithm

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 50 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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

Locations (1)

New York, New York, United States