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Biomarkers to improve prediction of heart failure risk

a biomarker and risk technology, applied in the field of laboratory diagnostics, can solve the problems of reducing the likelihood of heart failure in a patient, and the difficulty of diagnosing patients at risk for heart failure, so as to improve the risk of heart failure, and improve the diagnosis of hf risk.

Inactive Publication Date: 2014-09-18
BAYLOR COLLEGE OF MEDICINE +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

This patent is about improving the diagnosis of heart failure (HF) in patients. This can be done by measuring certain biomarkers in a patient's sample, like troponin and natriuretic peptide, and combining this data with patient data. This can improve the accuracy and speed of diagnosing HF risk.

Problems solved by technology

Preventative changes in diet, behavior, lifestyle, and other factors can dramatically decrease a patient's likelihood of experiencing heart failure, particularly if the risk is identified early.
However, diagnosing patients at risk for heart failure remains difficult, particularly due to the limitations of the currently available methods of heart failure prediction.
Consequently, the technical problem underlying the present disclosure could be seen as the provision of improved means and methods for identifying individuals that have an elevated risk of heart failure.

Method used

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  • Biomarkers to improve prediction of heart failure risk
  • Biomarkers to improve prediction of heart failure risk
  • Biomarkers to improve prediction of heart failure risk

Examples

Experimental program
Comparison scheme
Effect test

example 1

ARIC Study Population

[0078]The study population was generated using data obtained following the fourth ARIC examination (1997-99). From the 11,656 eligible individuals, those whose race was neither Black nor White (n=31), Black participants from the Washington County, Md. or Minneapolis centers (n=38), those with prevalent HF at examination 1 (n=410), those missing HF status at examination 1 (n=199), those missing covariates for ARIC HF model (n=354), those with HF hospitalization between examination 1 and 4 (n=229), those missing covariates for ARIC HF model (n=354), cTnT values (n=365), or NT-proBNP values (n=9), and those with extreme NT-proBNP≧6025 pg / ml (n=6), or not having given full consent (n=249) were excluded, leaving 9,868 individuals with adequate sample eligible for the analysis. Participants with biomarker levels below the detectable limit were assigned half the lower limit of detection. The mean age of the study population was 62.7 years; 44% were males, and ˜79.5% we...

example 2

Determination of cTnT and NT-proBNP Levels of ARIC Participants

[0079]Cardiac troponin T (cTnT) and NT-proBNP levels were measured using stored blood samples collected during the fourth ARIC examination described in Example 1.

[0080]Assays: Cardiac troponin T (cTnT) was measured using a 5th Generation, highly sensitive assay (Elecsys® Troponin T hs; Roche Diagnostics, Indianapolis, Ind. U.S.A.) (Hermsen, D. et al. 2007, Clin Lab.,53(1-2): 1-9). A cobas e 411 automated analyzer (Roche Diagnostics) was used to quantify the amount of cTnT. A detailed report on sources of variability, interassay reliability coefficients, repeatability of measurements and coefficients of variation in the ARIC study has been previously described (Agarwal et al., 2012, Circ Heart Fail. 5(4): 422-29; Saunders, A. T. et al., 2011, Circulation. 123(13): 1367-76). Briefly, the lower and upper limits of detection of the cTnT assay are 3 and 10,000 ng / L, respectively, and the limit of quantitation (the lowest anal...

example 3

Determination of Cox Hazard Ratios

[0083]Using Cox proportional hazards models, the hazard ratio for the association of cTnT (Table 2) and NT-proBNP (Table 3) with incident of HF was determined. Model factors were adjusted for age, race and cTnT (Table 3) or NT-proBNP (Table 2). Hazard ratios were also determined when model factors were adjusted for all components of the ARIC heart failure risk prediction model, and either cTnT (Table 3) or NT-proBNP (Table 2).

TABLE 2Hazard Ratios for Association of Troponin T (cTnT) with Heart Failure:The ARIC Study, 4th ExaminationTroponin categories (ng / L)MenWomenAge, race,Full ARIC,Age, race,Full ARIC,Model FactorsNT-proBNPNT-proBNPNT-proBNPNT-proBNPUndetectable11113 to ≦51.55 (1.00, 2.43)1.59 (1.02, 2.49)1.09 (0.82, 1.43)1.11 (0.84, 1.46)6 to ≦81.83 (1.19, 2.81)1.91 (1.24, 2.95)2.01 (1.54, 2.63)1.70 (1.29, 2.24) 9 to ≦132.28 (1.49, 3.50)2.14 (1.39, 3.30)3.10 (2.32, 4.15)2.47 (1.84, 3.33)14 to ≦254.78 (3.12, 7.33)3.80 (2.46, 5.88)6.03 (4.22, 8.62...

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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.

Description

[0001]The invention described herein was made with U.S. government support under contracts HHSN268201100005C, HHSN268201100006C, HHSN268201100007C, HHSN268201100008C, HHSN268201100009C, HH5N2682011000100, HHSN268201100011C, and HHSN268201100012C awarded by the National Heart, Lung, and Blood Institute. The U.S. government has certain rights in the invention.TECHNICAL FIELD[0002]The present disclosure relates to the field of laboratory diagnostics.BACKGROUND OF THE DISCLOSURE[0003]Among the various cardiovascular diseases, heart failure is projected to have the largest increases in incidence over the coming decades (Heidenreich, Circulation. 2011, 123(8): 933-44). As a matter of public health, it is of critical importance to identify patients at risk for heart failure. Preventative changes in diet, behavior, lifestyle, and other factors can dramatically decrease a patient's likelihood of experiencing heart failure, particularly if the risk is identified early. However, diagnosing pat...

Claims

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Application Information

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IPC IPC(8): G01N33/68
CPCG01N33/6887G01N33/6893G01N2800/52G01N2333/58G01N2800/325G01N2333/4712G16H50/30G01N33/74G01N2800/50
Inventor BALLANTYNE, CHRISTIE MITCHELLHOOGEVEEN, RON CORNELISNAMBI, VIJAYCHAMBLESS, LLOYD E.
Owner BAYLOR COLLEGE OF MEDICINE
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