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NCT06029452Completed

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)

Source: ClinicalTrials.gov · Last updated 3 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
558 (actual)
First submitted
1 Sept 2023
Start date
1 Sept 2023
Primary completion date
14 Nov 2023
Lead sponsor
Pfizer
NCT number
NCT06029452

What you commit to

  • Study type: Observational
  • Participants enrolled: 558
  • From 1 Sept 2023 to the primary completion date, 14 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

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

Who the study is looking for

  • 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.

Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pfizer
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.