N/A Completed N=558

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).

ATTR-CM

Source: ClinicalTrials.gov NCT06029452 ↗

Enrolled (actual)

558

Serious AEs

—

Results posted

Jan 2025

Primary outcomePrimary: Number of Participants According to Clinical Diagnosis Predicted Using the Machine Learning (ML) Algorithm — 203; 133; 35; 187 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants According to Clinical Diagnosis Predicted Using the Machine Learning (ML) Algorithm	203; 133; 35; 187	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06029452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.