N/A
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
Bottom Line
View on ClinicalTrials.gov: NCT06029452 ↗Enrolled (actual)
558
Serious AEs
—
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants According to Clinical Diagnosis Predicted Using the Machine Learning (ML) Algorithm — 203; 133; 35; 187 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Machine learning algorithm (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Nov 2023
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 | — |
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.
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
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.