Trial Outcomes & Findings for 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). (NCT NCT06029452)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

558 participants

Primary outcome timeframe

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

Results posted on

2025-01-03

Participant Flow

Participants with heart failure (HF) who met the inclusion and exclusion criteria were identified from the Optum electronic healthcare records (EHR) database between 01 January 2018 \& 30 April 2023 (approximately 5.4 years). Participants with clinical diagnosis of wild-type transthyretin amyloid cardiomyopathy (ATTRwt-CM) or non-amyloid HF were included in this retrospective study chart validation study. Available data was evaluated from 01 September 2023 to 14 November 2023 (up to 2.5 months).

Participant milestones

Participant milestones
Measure	ATTRwt-CM Participants Participants with clinical diagnosis of ATTRwt-CM between 01 January 2018 to 30 April 2023 were observed in this retrospective study. Available data of eligible participants were studied for 2.5 months in this retrospective observational study.	Non-amyloid HF Participants Participants with clinical diagnosis of non-amyloid HF between 01 January 2018 to 30 April 2023 were observed in this retrospective study. Available data of eligible participants were studied for 2.5 months in this retrospective observational study.
Overall Study STARTED	238	320
Overall Study COMPLETED	238	320
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATTRwt-CM Participants n=238 Participants Participants with clinical diagnosis of ATTRwt-CM between 01 January 2018 to 30 April 2023 were observed in this retrospective study. Available data of eligible participants were studied for 2.5 months in this retrospective observational study.	Non-amyloid HF Participants n=320 Participants Participants with clinical diagnosis of non-amyloid HF between 01 January 2018 to 30 April 2023 were observed in this retrospective study. Available data of eligible participants were studied for 2.5 months in this retrospective observational study.	Total n=558 Participants Total of all reporting groups
Age, Customized 50 to 65 Years	11 Participants n=238 Participants	73 Participants n=320 Participants	84 Participants n=558 Participants
Age, Customized >=65 years	227 Participants n=238 Participants	247 Participants n=320 Participants	474 Participants n=558 Participants
Sex: Female, Male Female	0 Participants n=238 Participants	0 Participants n=320 Participants	0 Participants n=558 Participants
Sex: Female, Male Male	238 Participants n=238 Participants	320 Participants n=320 Participants	558 Participants n=558 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

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

Population: Study population included all eligible participants with clinical diagnosis of ATTRwt-CM and Non-amyloid HF whose data was retrieved and evaluated in the study. Here, "Number of Participants Analyzed" signifies number of participants with respective actual clinical diagnosis ascertained by medical charts.

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.

Outcome measures

Outcome measures
Measure	ATTRwt-CM Participants n=238 Participants Participants with clinical diagnosis of ATTRwt-CM between 01 January 2018 to 30 April 2023 were observed in this retrospective study. Available data of eligible participants were studied for 2.5 months in this retrospective observational study.	Non-amyloid HF Participants n=320 Participants Participants with clinical diagnosis of non-amyloid HF between 01 January 2018 to 30 April 2023 were observed in this retrospective study. Available data of eligible participants were studied for 2.5 months in this retrospective observational study.
Number of Participants According to Clinical Diagnosis Predicted Using the Machine Learning (ML) Algorithm Predicted for ATTRwt-CM	203 Participants	133 Participants
Number of Participants According to Clinical Diagnosis Predicted Using the Machine Learning (ML) Algorithm Predicted for Non-amyloid HF	35 Participants	187 Participants

Adverse Events

ATTRwt-CM Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Non-amyloid HF Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer Clinical Trials.gov Call Center

Pfizer Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER