ATTR-CM Clinical Trial - A Retrospective Validation Study To Identify

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 Clinical Trial

Official title:
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)

Clinical Trial 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.

See also
Status	Clinical Trial	Phase
Completed	`NCT00935012` - Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy	Phase 3
Not yet recruiting	`NCT06465810` - Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis
Recruiting	`NCT05776212` - Quantitative-imaging in Cardiac Transthyretin Amyloidosis

See also

Status

Clinical Trial

Phase

Completed

NCT00935012 - Safety And Efficacy Evaluation Of Fx-1006a In Patients With V122i Or Wild-Type Transthyretin (TTR) Amyloid Cardiomyopathy

Phase 3

Not yet recruiting

NCT06465810 - Non-interventional Study of Patients With Transthyretin (ATTR) Amyloidosis

Recruiting

NCT05776212 - Quantitative-imaging in Cardiac Transthyretin Amyloidosis

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT06029452
Study type	Observational
Source	Pfizer
Contact
Status	Completed
Phase
Start date	September 1, 2023
Completion date	November 14, 2023

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).

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms