Methods predicting risk of an adverse clinical outcome
First Claim
1. A method for evaluating the risk of an adverse clinical outcome (ACO) in a subject having heart failure, the method comprising:
- (a) performing an assay to determine a level of galectin-3 in a biological sample from a subject having heart failure,(b) comparing the level of galectin-3 in the biological sample of (a) to a reference level of galectin-3;
(c) selecting a subject having an elevated level of galectin-3 in the biological sample of (a) as compared to the reference level of galectin-3;
(d) performing an assay to determine a level of soluble ST2 in a biological sample from the selected subject;
(e) comparing the level of soluble ST2 in the biological sample of (d) to a reference level of soluble ST2; and
(f) identifying a selected subject having an elevated level of soluble ST2 in the biological sample of (d) as compared to the reference level of soluble ST2 as having an increased risk of an ACO as compared to a subject having heart failure and an elevated level of galectin-3, who has a non-elevated level of soluble ST2, or identifying a selected subject having a non-elevated level of soluble ST2 in the biological sample of (d) as compared to the reference level of soluble ST2 as having a decreased risk of an ACO as compared to a subject having heart failure and an elevated level of galectin-3, who has an elevated level of soluble ST2.
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Abstract
Provided are methods for evaluating the risk of an adverse clinical outcome in a subject, deciding whether to discharge or continue treating a subject (e.g., on an inpatient basis), or to initiate or terminate treatment, selecting a subject for participation 5 in a clinical study, and selecting a therapeutic treatment for a subject that include determining a level of ST2 and a level of galectin-3 in a biological sample from the subject. Kits are also provided that contain an antibody that specifically binds to ST2, an antibody that specifically binds to galectin-3, and instructions for using the in the methods described.
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Citations
33 Claims
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1. A method for evaluating the risk of an adverse clinical outcome (ACO) in a subject having heart failure, the method comprising:
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(a) performing an assay to determine a level of galectin-3 in a biological sample from a subject having heart failure, (b) comparing the level of galectin-3 in the biological sample of (a) to a reference level of galectin-3; (c) selecting a subject having an elevated level of galectin-3 in the biological sample of (a) as compared to the reference level of galectin-3; (d) performing an assay to determine a level of soluble ST2 in a biological sample from the selected subject; (e) comparing the level of soluble ST2 in the biological sample of (d) to a reference level of soluble ST2; and (f) identifying a selected subject having an elevated level of soluble ST2 in the biological sample of (d) as compared to the reference level of soluble ST2 as having an increased risk of an ACO as compared to a subject having heart failure and an elevated level of galectin-3, who has a non-elevated level of soluble ST2, or identifying a selected subject having a non-elevated level of soluble ST2 in the biological sample of (d) as compared to the reference level of soluble ST2 as having a decreased risk of an ACO as compared to a subject having heart failure and an elevated level of galectin-3, who has an elevated level of soluble ST2. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18)
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19. A method for deciding whether to discharge or continue treating a subject having heart failure on an inpatient basis, comprising the steps of:
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(a) performing an assay to determine a level of galectin-3 in a biological sample from a subject having heart failure; (b) comparing the level of galectin-3 in the biological sample of (a) to a reference level of galectin-3; (c) selecting a subject who has an elevated level of galectin-3 in the biological sample of (a) as compared to the reference level of galectin-3; (d) performing an assay to determine a level of soluble ST2 in a biological sample from the selected subject; (e) comparing the level of soluble ST2 in the biological sample of (d) to a reference level of soluble ST2; and (f) determining that a selected subject having an elevated level of soluble ST2 in the biological sample of (d) as compared to the reference level of soluble ST2 should receive continued treatment on an inpatient basis, or that a selected subject having a non-elevated level of soluble ST2 in the biological sample of (d) as compared to the reference level of soluble ST2 should be discharged from inpatient treatment.
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20. A method of selecting a subject having heart failure for participation in a clinical study of a treatment for heart failure, comprising the steps of:
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(a) performing an assay to determine a level of galectin-3 in a biological sample from a subject having heart failure; (b) comparing the level of galectin-3 in the biological sample of (a) to a reference level of galectin-3; (c) identifying a subject having an elevated level of galectin-3 in the biological sample of (a) as compared to the reference level of galectin-3; (d) performing an assay to determine a level of soluble ST2 in a biological sample from the identified subject; (e) comparing the level of soluble ST2 in the biological sample of (d) to a reference level of soluble ST2; and (f) selecting an identified subject having an elevated level of soluble ST2 in the biological sample of (d) as compared to the reference level of soluble ST2 for participation in a clinical study of a treatment for heart failure.
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21. A method for selecting a therapeutic treatment for a subject having heart failure comprising the steps of:
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(a) performing an assay to determine a level of galectin-3 in a biological sample from a subject having heart failure; (b) comparing the level of galectin-3 in the biological sample of (a) to a reference level of galectin-3; (c) identifying a subject having an elevated level of galectin-3 in the biological sample of (a) as compared to the reference level of galectin-3; (d) performing an assay to determine the level of soluble ST2 in a biological sample from the identified subject; (e) comparing the level of soluble ST2 in the biological sample of (d) to a reference level of soluble ST2; and (f) selecting inpatient treatment for an identified subject having an elevated level of soluble ST2 in the biological sample of (d) as compared to the reference level of soluble ST2, or selecting outpatient treatment for an identified subject having a non-elevated level of soluble ST2 in the biological sample of (d) as compared to the reference level of soluble ST2. - View Dependent Claims (22, 23, 24, 25, 26)
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27. A method for evaluating the risk of an adverse clinical outcome (ACO) in a subject having heart failure, the method comprising:
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(a) selecting a subject having heart failure and an elevated level of galectin-3 as compared to the reference level of galectin-3; (d) performing an assay to determine a level of soluble ST2 in a biological sample from the selected subject; (e) comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2; and (f) identifying a selected subject having an elevated level of soluble ST2 in the biological sample as compared to the reference level of soluble ST2 as having an increased risk of an ACO as compared to a subject having heart failure and an elevated level of galectin-3, who has a non-elevated level of soluble ST2;
or identifying a selected subject having a non-elevated level of soluble ST2 in the biological sample as compared to the reference level of soluble ST2 as having a reduced risk of an ACO as compared to a subject having heart failure and an elevated level of galectin-3, who has an elevated level of soluble ST2. - View Dependent Claims (28, 29)
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30. A method for selecting a therapeutic treatment for a subject having heart failure comprising the steps of:
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(a) identifying a subject having an heart failure and an elevated level of galectin-3 as compared to the reference level of galectin-3 ; (b) performing an assay to determine the level of soluble ST2 in a biological sample from the identified subject; (c) comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2; and (d) selecting inpatient treatment for an identified subject having an elevated level of soluble ST2 in the biological sample as compared to the reference level of soluble ST2, or selecting outpatient treatment for an identified subject having a non-elevated level of soluble ST2 in the biological sample as compared to the reference level of soluble ST2. - View Dependent Claims (31, 32, 33)
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Specification