NCT06029452

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).

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 558 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ATTR-CM

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-01
• Primary completion: 2023-11-14
• Completion: 2023-11-14
• First posted: 2023-09-08
• Last updated: 2025-01-03
• Results posted: 2025-01-03

Locations

1 site across 1 country: United States