Methods for predicting risk of developing hypertension

Abstract

Methods using biomarkers, e.g., serum levels of ST2, to predict risk of developing hypertension, as well as methods for treating subjects to reduce the risk of developing hypertension and methods for selecting and/or stratifying subjects for clinical trials of treatments to reduce the risk of hypertension.

What is claimed is: 
     
         1 . A method for selecting a treatment for a subject, the method comprising:
 determining a level of soluble ST2 in a biological sample from a subject;   comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2; and   selecting an anti-hypertensive therapy for a subject having an elevated level of soluble ST2 in the biological sample compared to the reference level of soluble ST2.   
     
     
         2 . The method of  claim 1 , wherein the reference level of soluble ST2 is a level of soluble ST2 in a healthy subject. 
     
     
         3 . The method of  claim 1 , wherein the biological sample comprises blood, serum, or plasma. 
     
     
         4 . The method of  claim 1 , further comprising:
 determining the level of one of more additional biomarkers selected from the group consisting of: atrial natriuretic peptide (ANP), proANP, N-terminal (NT)-proANP, brain natriuretic peptide (BNP), proBNP, NT-proBNP, cardiac troponin I, C-reactive protein, creatinine, and Blood Urea Nitrogen (BUN) in the biological sample;   comparing the level of the one or more additional biomarkers in the biological sample to a reference level of the one of more additional biomarkers; and   selecting an anti-hypertensive therapy for a subject having an elevated level of the one or more additional biomarkers in the biological sample compared to the reference level of the one or more additional biomarkers.   
     
     
         5 . The method of  claim 4 , wherein the one or more additional biomarkers are selected from the group consisting of BNP, proBNP, and NT-proBNP. 
     
     
         6 . A method of treating a subject, the method comprising:
 determining a level of soluble ST2 in a biological sample from a subject;   comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2; and   administering to a subject having an elevated level of soluble ST2 in the biological sample compared to the reference level of soluble ST2 an anti-hypertensive therapy, or monitoring a subject decreased low level of soluble ST2 in the biological sample compared to the reference level of soluble ST2.   
     
     
         7 . The method of  claim 6 , wherein the reference level of soluble ST2 is a level of soluble ST2 in a healthy subject. 
     
     
         8 . The method of  claim 6 , wherein the biological sample comprises blood, serum, or plasma. 
     
     
         9 . The method of  claim 6 , further comprising:
 determining the level of one of more additional biomarkers selected from the group consisting of: atrial natriuretic peptide (ANP), proANP, N-terminal (NT)-proANP, brain natriuretic peptide (BNP), proBNP, NT-proBNP, cardiac troponin I, C-reactive protein, creatinine, and Blood Urea Nitrogen (BUN) in the biological sample;   comparing the level of the one or more additional biomarkers in the biological sample to a reference level of the one of more additional biomarkers; and   administering to a subject having an elevated level of the one or more additional biomarkers in the biological sample compared to the reference level of the one or more additional biomarkers an anti-hypertensive therapy, or monitoring a subject having decreased low level of the one or more additional biomarkers in the biological sample compared to the reference level of the one or more additional biomarkers.   
     
     
         10 . The method of  claim 6 , wherein the one or more additional biomarkers are selected from the group consisting of BNP, proBNP, and NT-proBNP. 
     
     
         11 . A method for selecting a subject for participation in a clinical study of a treatment for reducing the risk of developing hypertension, the method comprising:
 determining a level of soluble ST2 in a biological sample from a subject;   comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2; and   selecting a subject having an elevated level of soluble ST2 in the biological sample compared to the reference level of soluble ST2 for participation in a clinical trial of a treatment for reducing the risk of developing hypertension.   
     
     
         12 . The method of  claim 11 , wherein the reference level of soluble ST2 is a level of soluble ST2 in a healthy subject. 
     
     
         13 . The method of  claim 11 , wherein the biological sample comprises blood, serum, or plasma. 
     
     
         14 . The method of  claim 11 , further comprising:
 determining the level of one of more additional biomarkers selected from the group consisting of: atrial natriuretic peptide (ANP), proANP, N-terminal (NT)-proANP, brain natriuretic peptide (BNP), proBNP, NT-proBNP, cardiac troponin I, C-reactive protein, creatinine, and Blood Urea Nitrogen (BUN) in the biological sample;   comparing the level of the one or more additional biomarkers in the biological sample to a reference level of the one of more additional biomarkers; and   selecting a subject having an elevated level of the one or more additional biomarkers in the biological sample compared to the reference level of the one or more additional biomarkers for participation in a clinical trial of a treatment for reducing the risk of a developing hypertension.   
     
     
         15 . The method of  claim 11 , wherein the one or more additional biomarkers are selected from the group consisting of BNP, proBNP, and NT-proBNP. 
     
     
         16 . A method for evaluating the risk of developing hypertension in a subject, the method comprising:
 determining a level of soluble ST2 in a biological sample from a subject;   comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2; and   identifying a subject having an elevated level of soluble ST2 in the biological sample compared to the reference level of soluble ST2 as having an increased risk of developing hypertension, or identifying a subject having decreased low level of soluble ST2 in the biological sample compared to the reference level of soluble ST2 as having a decreased risk of developing hypertension.   
     
     
         17 . The method of  claim 16 , wherein the reference level of soluble ST2 is a level of soluble ST2 in a healthy subject. 
     
     
         18 . The method of  claim 16 , wherein the risk of developing hypertension is the risk of developing hypertension within three years. 
     
     
         19 . The method of  claim 16 , wherein the biological sample comprises blood, serum, or plasma. 
     
     
         20 . The method of  claim 16 , further comprising:
 determining the level of one of more additional biomarkers selected from the group consisting of: atrial natriuretic peptide (ANP), proANP, N-terminal (NT)-proANP, brain natriuretic peptide (BNP), proBNP, NT-proBNP, cardiac troponin I, C-reactive protein, creatinine, and Blood Urea Nitrogen (BUN) in the biological sample;   comparing the level of the one or more additional biomarkers in the biological sample to a reference level of the one of more additional biomarkers; and   identifying a subject having an elevated level of the one or more additional biomarkers in the biological sample compared to the reference level of the one or more additional biomarkers as having an increased risk of developing hypertension.   
     
     
         21 . The method of  claim 20 , wherein the one or more additional biomarkers are selected from the group consisting of BNP, proBNP, and NT-proBNP. 
     
     
         22 . The method of any one of  claims 1 - 21 , wherein the subject is human. 
     
     
         23 . A kit for use in a method described herein, the kit comprising an antibody that specifically binds to soluble ST2; and optionally instructions for performing any of the methods of  claims 1 - 22 .