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1. WO2017076974 - BIOMARQUEUR POUR LA STRATIFICATION DU RISQUE DANS UNE MALADIE CARDIOVASCULAIRE

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CLAIMS

miR-1306-5p for use as a biomarker in the risk stratification of human patients suffering from heart failure (HF), or of human patients suspected to suffer from HF.

An in vitro method for risk stratification of a human HF patient, or of a patient suspected to suffer from HF, the method comprising the steps of:

a) determining the level of miR-1306-5p in a biological sample from the patient; b) comparing the level determined in step a) to the level of miR-1306-5p in a standard sample; and

c) determining the risk of re-hospitalization and/or mortality of the patient, wherein an increase in the level of miR-1306-5p in the biological sample compared to the level of miR-1306-5p in the standard sample is indicative for an increased risk.

A method for risk stratification of a human HF patient, or of a human patient suspected to suffer from HF, the method comprising the steps of:

a) obtaining a biological sample from the patient;

b) determining the level of miR-1306-5p in the biological sample;

c) comparing the level determined in step b) to the level of miR-1306-5p in a standard sample; and

d) determining the risk of re-hospitalization and/or mortality of the patient, wherein an increase in the level of miR-1306-5p in the biological sample compared to the level of miR-1306-5p in the standard sample is indicative for an increased risk.

A method of treatment of a human HF patient, or of a human patient suspected to suffer from HF, the method comprising the steps of:

a) obtaining a biological sample from the patient;

b) comparing the level of miR-1306-5p in the biological sample to the level of miR- 1306-5p in a standard sample;

c) treating the patient in the event that the level of miR-1306-5p in the biological sample compared to the level of miR-1306-5p in the standard sample is indicative for an increased risk of re-hospitalization and/or mortality.

5. The method according to any one of claims 2 to 4, wherein the risk is determined for a period of approximately four, three, two, or preferably approximately one year following sampling the biological sample.

6. The method according to any one of claims 2 to 5, wherein the risk is determined by adding the patient's weighted value of one or more established risk factors for HF.

7. The method according to any of claims 2 to 6, wherein the risk is determined by adding the weighted value of the level of NT-proBNP in a biological sample from the patient in comparison to the NT-proBNP level in a standard sample.

8. The method according to any one of claims 2 to 7, wherein the standard sample is from an HF patient not having experienced a worsening condition due to HF within one year following sampling, or from a healthy individual.

9. The method according to any one of claims 2 to 8, wherein the biological sample is a blood sample.

10. The method of claim 9, wherein the blood sample is a serum sample or a plasma sample.

1 1 . An method of determining whether a human HF patient is at risk of suffering from a worse condition due to HF within four, three, two or one year from sampling, comprising:

a) determining in a biological sample from said patient the expression of miR- 1306-5p; and

b) determining in a standard sample the expression of miR-1306-5p;

wherein an upregulation of miR-1306-5p in said biological sample in comparison to the level in said standard sample is indicative for a risk of a worsening condition of said patient due to HF, and wherein said standard sample is from a HF patient not having experienced a worse condition within one year following sampling, or from a healthy individual.

12. Use of miR-1306-5p as a biomarker in the risk stratification of human patients suffering from heart failure (HF), or of human patients suspected to suffer from HF.