Metabolic biomarkers for assessing heart failure in a single ventricle pediatric subject
AssigneeThe Trustees of Indiana University
InventorsRonald Mark Payne, Thomas Michael O'Connell
Life of this patent
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Abstract
Methods to assess a pediatric subject having a single ventricle heart include identifying a difference between concentration levels of metabolic biomarkers and reference concentration levels and then assessing the pediatric subject based on the identified differences.
Claims78
A method to assess a pediatric subject having a single ventricle heart, the method comprising:
- determining a concentration level of one or more validated low molecular weight metabolic biomarkers in a biological sample from the subject;
- identifying a difference between the determined concentration level of the one or more metabolic biomarkers and a reference concentration level of the one or more metabolic biomarkers;
- and,
- assessing the pediatric subject based on the identified difference.
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A diagnostic kit for assessing an attribute of heart failure in a pediatric subject having a single ventricle heart disease, where the attribute of heart failure is associated with a low molecular weight metabolic biomarker profile, the kit comprising:
- a container comprising
- at least one validated low molecular weight metabolic biomarker internal standard having a purity greater than 98.0%,
- a sample receiving vessel for receiving a biological sample, and
- a sealing member for sealing the sample receiving vessel after receiving the biological sample.
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A method to identify a candidate low molecular weight metabolic biomarker that differentiates a pediatric subject having a single ventricle heart without heart failure and a pediatric subject that has a single ventricle heart with heart failure, the method comprising:
- obtaining a first biological sample from a pediatric subject having a single ventricle heart without heart failure and a second biological sample from a pediatric subject having a single ventricle heart with heart failure;
- determining a concentration level of one or more low molecular weight metabolic biomarkers in the first biological sample and the second biological sample;
- and,
- identifying one or more validated low molecular weight metabolic biomarkers that are present in a statistically significant, different level in the first and second biological samples, where the different level is characterized by an area under the receiver operator characteristic (ROC) curve (AUC) ranging from 0.60 to 1.00.
Dependencies are inferred from the claim text.