BIOMARKERS TO IMPROVE PREDICTION OF HEART FAILURE RISK

• US 20140273273A1
• Filed: 10/31/2013
• Published: 09/18/2014
• Est. Priority Date: 11/01/2012
• Status: Abandoned Application

• Current Assignee: Baylor College of Medicine (Baylor College), University of North Carolina At Chapel Hill (University of North Carolina System)
• Original Assignee: University of North Carolina At Chapel Hill (University of North Carolina System)
• Inventors: Ballantyne, Christie Mitchell, Hoogeveen, Ron Cornelis, Nambi, Vijay, Chambless, Lloyd E.
• Application Number:
  US14/068,816
• Publication Number:
  US 20140273273A1
• Time in Patent Office: Days
• US Class Current: 436/501
• CPC Class Codes: G01N 2333/4712 Muscle proteins, e.g. myosin, actin, protein
• CPC Class Codes: G01N 2333/58 Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
• CPC Class Codes: G01N 2800/325 Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure
• CPC Class Codes: G01N 2800/50 Determining the risk of developing a disease
• CPC Class Codes: G01N 2800/52 Predicting or monitoring the response to treatment, e.g. for selection of therapy based on assay results in personalised medicine; Prognosis
• CPC Class Codes: G01N 33/6887 from muscle, cartilage or connective tissue
• CPC Class Codes: G01N 33/6893 related to diseases not provided for elsewhere
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

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.

Claims

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.