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 | Completed Results

• 1 other identifier: B3461111
• Study Type: observational
• Target: 558
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• Number of Participants According to Clinical Diagnosis Predicted Using the Machine Learning (ML) Algorithm

  In this outcome measure number of participants were reported according to clinical diagnosis predicted by ML algorithm. True positive (TP) = participants with actual and predicted diagnosis of ATTRwt-CM; False positive (FP) = participants with actual diagnosis of non-amyloid HF and predicted diagnosis of ATTRwt-CM; False negative (FN) = participants with actual diagnosis of ATTRwt-CM and predicted diagnosis of non-amyloid HF; True negative (TN) = participants with actual and predicted diagnosis of non-amyloid HF.

  At diagnosis, anytime during retrospective data identification period of approximately 5.4 years; retrospective data observed in this study for approximately 2.5 months

Study Arms (1)

ATTRwt-CM and non-amyloid heart failure patients

Other: Machine learning algorithm

Interventions

Machine learning algorithm OTHER

Software to calculate the predicted probability of ATTRwt-CM for these heart failure patients based on the presence and absence of certain features

ATTRwt-CM and non-amyloid heart failure patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Heart failure patients with clinical diagnosis of ATTRwt-CM or non-amyloid HF

You may qualify if:

• 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.

You may not qualify if:

• Patients with any of the following diagnoses:
• Light chain (AL) amyloidosis
• Intracranial hemorrhage
• Cerebral amyloid angiopathy
• End stage renal disease
• Blood cancer

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer

New York, New York, 10018, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Machine Learning Algorithms

Intervention Hierarchy (Ancestors)

Algorithms; Mathematical Concepts

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: September 1, 2023
• Primary Completion: November 14, 2023
• Study Completion: November 14, 2023
• Last Updated: January 3, 2025
• Results First Posted: January 3, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)