METHODS AND COMPOSITIONS FOR MONITORING HEART FAILURE

摘要

The present invention provides methods and compositions for monitoring of subjects suffering from, or being evaluated for, heart failure. A filtered Natriuretic peptide time-series, alone or in combination with other clinical indicia such as weight gain, can be used to estimate a patient's hazard (risk of decompensation). The cumulative integral of Natriuretic peptide concentration can be used to estimate cumulative hazard (risk times exposure) over longer periods of exposure, e.g., 14 day periods, or 30 day periods.

主权项

1. A method of providing an indication of heart failure risk in a non-hospitalized individual diagnosed with heart failure, comprising:
obtaining a plurality of measured Natriuretic peptide concentrations, each measurement obtained by performing an assay which detects one or more biomarkers selected from the group consisting of BNP, NT-proBNP, and proBNP in a body fluid of the individual, said plurality comprising at least two measurements made on different days within a period of not more than fourteen days, and preferably not more than seven days, to provide a Natriuretic peptide concentration series, wherein each measurement comprises a first signal component related to the heart failure risk of the individual and a second signal component related to noise, and wherein each measurement is obtained by introducing a body fluid sample obtained from the patient into an assay instrument which (i) contacts the sample with a binding reagent that specifically binds to the one or more biomarkers, (ii) generates a signal corresponding to the amount of the one or more biomarkers present in the sample, (iii) determines a Natriuretic peptide concentration from the signal generated, and (iv) stores the Natriuretic peptide concentration on a computer storage medium; and providing the indication of heart failure risk using a computer processor operably connected to the computer storage medium, wherein the computer processor is configured to (a) transform the series of Natriuretic peptide concentrations to provide a transformed data series, (b) process the transformed data series to produce output data comprising a data contribution from the first signal component, wherein the output data reduces at least a substantial portion of a data contribution attributable to the noise component, and (c) determine the indication of heart failure risk using the output data.