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US 10,436,798 B2Granted
Means and methods for diagnosing and monitoring heart failure in a subject
AssigneesMetanomics GmbH, Ruprecht-Karls-UniversitäT Heidelberg
InventorsRegina Reszka, Jens Fuhrmann, Jürgen Kastler, Bianca Bethan, Martin Kluttig, Hugo A. Katus, Norbert Frey, Johanna Wolf, Tanja Weis
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Abstract
The present invention relates to the field of diagnostic methods. Specifically, the present invention contemplates a method for diagnosing heart failure in a subject and a method for monitoring progression or regression of heart failure in a subject. The invention also relates to tools for carrying out the aforementioned methods, such as diagnostic devices.
Claims20
A method for identifying and treating a subject suffering from heart failure and in need for a therapy of heart failure, comprising:
- 1) providing an indicator of heart failure in a subject comprising:
- a) obtaining a test sample of a subject suspected to suffer from heart failure or having heart failure, wherein the heart failure is DCMP (Dilated Cardiomyopathy), ICMP (Ischemic Cardiomyopathy), or HCMP (Hypertrophic Cardiomyopathy), and wherein the test sample was pretreated using one or more of the following methods:
- centrifugation and/or derivatization;
- b) determining, using mass spectrometry, in the sample:
- (i) the amounts of
- (1) at least three biomarkers selected from the biomarkers listed in Tables 1A1 and 1A2, which are biomarkers of all asymptomatic CHF patients with NYHA I;
- or
- (2) at least three biomarkers selected from the biomarkers listed in Tables 2A1 and 2A2, which are biomarkers for asymptomatic CHF (DCMP) patients with NYHA I;
- or
- (3) at least three biomarkers selected from the biomarkers listed in Tables 3A1 and 3A2, which are biomarkers for asymptomatic CHF (ICMP) patients with NYHA I;
- or
- (4) at least three biomarkers selected from the biomarkers listed in Tables 4A1 and 4A2, which are biomarkers for asymptomatic CHF (HCMP) patients with NYHA I;
- or
- (5) at least three biomarkers selected from the biomarkers listed in Tables 5A1 and 5A2, which are biomarkers for symptomatic CHF patients with NYHA II or III;
- or
- (6) at least three biomarkers selected from the biomarkers listed in Tables 6A1 and 6A2, which are biomarkers for symptomatic DCMP patients with NYHA II or III, wherein the at least three biomarkers do not include glutamate, kynurenine, 3-Methoxytyrosine, Isocitrate, alpha-Ketoglutarate, Malate, Choline, Uric acid, Creatine, Psuedouridine, myo-lnositol, Tyrosine, or Phenylalanine;
- or
- (7) at least three biomarkers selected from the biomarkers listed in Tables 7A1 and 7A2, which are biomarkers for symptomatic ICMP patients with NYHA II or III;
- or
- (8) at least three biomarkers selected from the biomarkers listed in Tables 8A1 and 8A2, which are biomarkers for symptomatic HCMP patients with NYHA II or III;
- wherein said sample is a plasma or serum sample;
- or
- (ii) the amounts of
- (1) at least three biomarkers selected from the biomarkers listed in Tables 1B1 and 1B2, which are biomarkers of all asymptomatic CHF patients with NYHA I;
- or
- (2) at least three biomarkers selected from the biomarkers listed in Tables 2B1 and 2B2, which are biomarkers for asymptomatic CHF (DCMP) patients with NYHA I;
- or
- (3) at least three biomarkers selected from the biomarkers listed in Tables 3B1 and 3B2, which are biomarkers for asymptomatic CHF (ICMP) patients with NYHA I;
- or
- (4) at least three biomarkers selected from the biomarkers listed in Tables 4B1 and 4B2, which are biomarkers for asymptomatic CHF (HCMP) patients with NYHA I;
- or
- (5) at least three biomarkers selected from the biomarkers listed in Tables 5B1 and 5B2, which are biomarkers for symptomatic CHF patients with NYHA II or III;
- or
- (6) at least three biomarkers selected from the biomarkers listed in Tables 6B1 and 6B2, which are biomarkers for symptomatic DCMP patients with NYHA II or III;
- or
- (7) at least three biomarkers selected from the biomarkers listed in Tables 7B1 and 7B2, which are biomarkers for symptomatic ICMP patients with NYHA II or III;
- or
- (8) at least three biomarkers selected from the biomarkers listed in Tables 8B1 and 8B2, which are biomarkers for symptomatic HCMP patients with NYHA II or III;
- wherein said sample is a urine sample;
- and
- c) comparing the amounts of the said at least three biomarkers to a reference, whereby an indicator of heart failure is provided and, based on the comparison, identifying whether the subject suffers from heart failure and, if the subject suffers from heart failure, identifying the subject as a subject in need for a therapy of heart failure;
- and
- 2) if the subject is identified as a subject in need for a therapy of heart failure, treating the subject by administering at least one drug selected from ACE Inhibitors (ACEI), Beta Blockers, AT1-Inhibitors, Aldosteron Antagonists, Renin Antagonists, Diuretics, Ca-Sensitizer, Digitalis Glykosides, polypeptides of the protein S100 family, or natriuretic peptides.
40 more elements
A method of monitoring progression or regression of heart failure in a subject and treating a subject in need of therapy of heart failure, comprising:
- a) obtaining a test sample of a subject known to suffer from heart failure, wherein the heart failure is DCMP (Dilated Cardiomyopathy), ICMP (Ischemic Cardiomyopathy), or HCMP (Hypertrophic Cardiomyopathy), and wherein the test sample was pretreated using one or more of the following methods:
- centrifugation and/or derivatization;
- b) determining, using mass spectrometry, in a first and a second sample of said subject:
- (i) the amounts of:
- (1) at least three biomarkers selected from the biomarkers listed in Tables 9A1 and 9A2;
- or
- (2) at least three biomarkers selected from the biomarkers listed in Tables 10A1 and 10A2, wherein the at least three biomarkers do not include glutamate, 3-Methoxytyrosine, Isocitrate, alpha-Ketoglutarate, and Uric acid;
- or
- (3) at least three biomarkers selected from the biomarkers listed in Tables 11A1 and 11A2;
- or
- (4) at least three biomarkers selected from the biomarkers listed in Tables 12A1 and 12A2;
- or
- (5) at least three biomarkers selected from the biomarkers listed in Tables 13A1 and 13A2;
- wherein said sample is a plasma or serum sample;
- or
- (ii) the amounts of:
- (1) at least three biomarkers selected from the biomarkers listed in Tables 9B31 and 9B2;
- or
- (2) at least three biomarkers selected from the biomarkers listed in Tables 10B1 and 10B2;
- or
- (3) at least three biomarkers selected from the biomarkers listed in Tables 11B1 and 11B2;
- or
- (4) at least three biomarkers selected from the biomarkers listed in Tables 12B1 and 12B2;
- or
- (5) at least three biomarkers selected from the biomarkers listed in Tables 13B1 and 13B2;
- wherein said sample is a urine sample;
- and
- wherein said first sample has been obtained prior to said second sample;
- and
- c) comparing the amounts of the at least three biomarkers determined in the first sample with the amounts of the at least three biomarkers determined in the second sample, whereby progression or regression of heart failure is monitored and, based on the comparison, identifying whether heart failure has progressed and, if so, identifying the subject as a subject in need for a therapy of heart failure;
- and
- d) if the subject is identified as a subject in need for a therapy of heart failure, treating the subject by administering at least one drug selected from ACE Inhibitors (ACEI), Beta Blockers, AT1-Inhibitors, Aldosteron Antagonists, Renin Antagonists, Diuretics, Ca-Sensitizer, Digitalis Glykosides, polypeptides of the protein S100 family, or natriuretic peptides.
29 more elements
Dependencies are inferred from the claim text.