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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ATTRwt-CM and non-amyloid heart failure patients |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Patients with any of the following diagnoses:
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Heart failure patients with clinical diagnosis of ATTRwt-CM or non-amyloid HF
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer | New York | New York | 10018 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Non-amyloid HF Participants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2023 |
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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. |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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. | 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. | Posted | Count of Participants | Participants | At diagnosis, anytime during retrospective data identification period of approximately 5.4 years; retrospective data observed in this study for approximately 2.5 months |
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Not applicable as adverse events were not collected for the study
Due to non-interventional nature of study and nature of data sources, the minimum criteria for reporting an adverse event (that is, identifiable participant, identifiable reporter, a suspect product, and event) could not be met, hence adverse events were not planned to be collected and reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Clinical Trials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Nov 7, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000098435 | Machine Learning Algorithms |
| ID | Term |
|---|---|
| D000465 | Algorithms |
| D055641 | Mathematical Concepts |
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| >=65 years |
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| Specificity |
| 0.584 |
| 1-Sided |
| 95 |
| 0.539 |
Sensitivity was defined as the probability that an individual with the disease in the population were screen positive for disease by the algorithm (TP). Sensitivity = TP / (TP + FN). |
| Non-Inferiority |
Non-inferiority margin was 0.10. |