Biomarkers to improve prediction of heart failure risk

Abstract

The present disclosure relates to the field of laboratory diagnostics. Specifically, methods are disclosed for determining a patient's risk of suffering from heart failure (HF) based on the detection of NT-proBNP, troponin T, and/or a natriuretic peptide. Also disclosed are methods for improving both the accuracy and speed of HF risk models by incorporating biomarker data from patient samples.

What is claimed is: 
     
         1 . A method for diagnosing heart failure risk in a subject, comprising:
 a. obtaining the subject's simplified model factors;   b. obtaining the amount of Troponin T (TnT) and NT-pro B-type natriuretic peptide (NT-proBNP) in a biological sample obtained from the subject;   c. obtaining a simplified model score based on the amount of TnT and NT-proBNP in the biological sample obtained from the subject and the subject's simplified model factors;   d. obtaining the alignment value of the simplified model score compared to a clinical model score; and   e. providing a diagnosis of heart failure risk if the alignment value exceeds a threshold.   
     
     
         2 . A method for identifying a subject as in need of therapy for heart failure, comprising:
 a. obtaining the subject's simplified model factors;   b. contacting a portion of a biological sample obtained from the subject with an antibody immunoreactive for Troponin T (TnT);   c. contacting a portion of the biological sample obtained from the subject with an antibody immunoreactive for a NT-pro B-type natriuretic peptide (NT-proBNP);   d. determining an amount of TnT and an amount of NT-proBNP in the biological sample obtained from the subject;   e. determining a simplified model score based on the amount of TnT and NT-proBNP in the biological sample obtained from the subject and the subject's simplified model factors;   f. comparing the simplified model score to a clinical model score to determine an alignment value; and   g. identifying the subject as in need of therapy for heart failure if the alignment value is above a threshold.   
     
     
         3 . A method for facilitating a therapeutic decision in a subject, comprising:
 a. obtaining the subject's simplified model factors;   b. contacting a first portion of a biological sample obtained from the subject with a first antibody immunoreactive for Troponin T (TnT) and contacting a second portion of the biological sample obtained from the subject with a second antibody immunoreactive for a NT-pro B-type natriuretic peptide (NT-proBNP);   c. determining an amount of TnT and an amount of NT-proBNP in the biological sample obtained from the subject;   d. determining a simplified model score based on the amount of TnT and NT-proBNP in the biological sample obtained from the subject and the subject's simplified model factors; and   e. fitting the simplified model score/curve to a clinical model score;   
       wherein a fit above a threshold is indicative of a need for therapy for heart failure risk. 
     
     
         4 . A method of selecting a treatment for a subject with heart failure risk, comprising:
 a. obtaining the subject's simplified model factors;   b. contacting a portion of a biological sample obtained from the subject with an antibody immunoreactive for Troponin T (TnT);   c. contacting a portion of the biological sample obtained from the subject with an antibody immunoreactive for a NT-pro B-type natriuretic peptide (NT-proBNP);   d. determining an amount of TnT and an amount of NT-proBNP in the biological sample obtained from the subject based on said steps of contacting;   e. calculating a simplified model score based on the amount of TnT and NT-proBNP determined in said step of determining and the subject's simplified model factors;   f. aligning the simplified model score to a clinical model score; and   g. selecting a treatment for heart failure when the simplified model score significantly aligns to the clinical model score.   
     
     
         5 . A model for predicting risk of heart failure in a subject, comprising:
 a. simplified model factors obtained from the subject;   b. an amount of Troponin T (TnT) in a biological sample obtained from the subject; and   c. an amount of NT-pro B-type natriuretic peptide (NT-proBNP) in a biological sample obtained from the subject;   wherein the simplified model factors, amount of TnT, and amount of NT-proBNP are operatively combined/calculated to predict risk of heart failure in a subject.   
     
     
         6 . A system/device/assay adapted for facilitating a therapeutic decision in a subject, comprising:
 a. means for contacting a first portion of a biological sample from the subject with a first antibody immunoreactive for Troponin T (TnT);   b. means for contacting a second portion of the biological sample obtained from the subject with a second antibody immunoreactive for NT-pro B-type natriuretic peptide (NT-proBNP);   c. a computing device having a processor; and   d. a non-transient machine readable media including a plurality of instructions executable by the processor, the instructions, when executed, determine a simplified model score based on the amount of TnT and NT-proBNP in the biological sample obtained from the subject and the subject's simplified model factors, and provide an output indicating a need for therapy for heart failure risk in the subject if the simplified model score significantly aligns to a clinical model score.   
     
     
         7 . A method of predicting a clinical heart failure risk score in a subject, comprising:
 a. obtaining the subject's simplified model factors;   b. obtaining the amount of Troponin T (TnT) and NT-pro B-type natriuretic peptide (NT-proBNP) in a biological sample obtained from the subject;   c. obtaining a simplified model score based on the amount of TnT and NT-proBNP in the biological sample obtained from the subject and the subject's simplified model factors;   d. obtaining the alignment value of the simplified model score compared to a clinical model score; and   e. predicting a clinical heart failure risk score if the alignment value exceeds a threshold.   
     
     
         8 . A method of improving the prediction accuracy of a clinical heart failure risk score for a subject, comprising:
 a. obtaining the clinical heart failure risk score for the subject;   b. obtaining an amount of Troponin T (TnT) and an amount of NT-pro B-type natriuretic peptide (NT-proBNP) in a biological sample obtained from the subject; and   c. combining the amount of TnT and NT-proBNP with the clinical heart failure risk score to improve the prediction accuracy of the clinical heart failure risk score for the subject.