# US 11,112,414 B2 · Biomarker of rehospitalization after heart failure

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- Number: US 11,112,414 B2
- Document ID: US11112414B2
- Status: Granted
- Kind: B2
- Application number: 14/895,076
- Filed: 2014-06-06
- Published: 2016-05-05
- Granted: 2021-09-07
- Earliest claimed: 2013-06-06
- Assignees: Inserm (Institute National De Las Sante Et De La Recherche Medicale); Universite Paul Sabatier Toulouse III; Centre Hospitalier Univeersitaire De Toulouse
- Applicants: INSERM (Institut National de la Sante et de la Recherche Medicale); Universite Paul Sabatier Toulouse III; Centre Hospitalier Universitaire de Toulouse
- Inventors: Philippe Rouet; Fatima Smith-Rouet; Franck Desmoulin; Michel Galinier
- Web page: https://patentgrep.com/patent/US11112414B2

## CPC

- G01N 33/6893: {related to diseases not provided for elsewhere}
- G01N 33/74: involving hormones {or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors}
- G01N 2333/4704: Inhibitors; Supressors
- G01N 2333/4745: Insulin-like growth factor binding protein
- G01N 2800/325: Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure
- G01N 2800/56: Staging of a disease; Further complications associated with the disease
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)

## Abstract

The invention is a method for treating a heart failure patient with the steps of measuring the concentration of IGFBP2 in a blood, plasma or urine sample obtained from the heart failure patient and comparing the patient's IGFBP2 level to a threshold value derived from IGFBP2 measured in samples taken from a group of patients with heart failure selected from the group consisting of stage I, stage stage III and stage IV heart failure, according to New York Heart Association (NYHA) classification system. A patient with an IGFBP2 level that exceeds the threshold value is admitted or readmitted to a hospital and treated with at least one treatment selected from the group consisting of administration of a beta-blocker, an angiotensin-converting enzyme inhibitor, an angiotensin receptor blocker, an aldosterone antagonist, an implantable cardiac defibrillator, a cardiac resynchronization therapy, an implantable left ventricular assist device and a heart transplant.

## Claims

### Claim 1

A method for avoiding rehospitalization and treating a heart failure patient with a clinical diagnosis of heart failure, wherein said method comprises
obtaining a biological sample selected from the group consisting of blood, plasma, and urine from said patient,
measuring the concentration of IGFBP2 in said sample obtained from said patient with the clinical diagnosis of heart failure, and
comparing the concentration of IGFBP2 measured in said measuring step to a threshold value derived from the concentration of IGFBP2 in blood samples taken from a group of patients wherein each of the patients in the group has one or more stages of heart failure selected from the group consisting of stage I, stage II, stage III and stage IV, according to the New York Heart Association (NYHA) heart failure classification system,
rehospitalizing said patient with the clinical diagnosis of heart failure if the measured concentration exceeds the threshold value, and
administering to said patient with the clinical diagnosis of heart failure at least one treatment selected from the group consisting of an effective amount of a beta-blocker, an effective amount of an angiotensin-converting enzyme inhibitor, an effective amount of an angiotensin receptor blocker, an effective amount of an aldosterone antagonist, an implantable cardiac defibrillator, a cardiac resynchronization therapy, an implantable left ventricular assistive device and a heart transplant,
wherein the clinical diagnosis of heart failure is a diagnosis of heart failure with either reduced or preserved ejection fraction.

### Claim 2 (depends on 1)

The method according to claim 1, wherein said sample is plasma.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the concentration of IGFBP2 is measured by quantifying the level of IGFBP2 protein in the sample.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the quantification of the level of IGFBP2 protein is performed by using a set of antibodies directed against IGFBP2.

### Claim 5 (depends on 3)

The method according to claim 3, wherein the quantification of the level of IGFBP2 protein is performed by ELISA.

### Claim 6 (depends on 3)

The method according to claim 3, wherein the quantification of the level of IGFBP2 protein is performed by capillary electrophoresis-mass spectroscopy technique (CE-MS).

### Claim 7

A method for treating a heart failure patient who has been previously hospitalized for heart failure, comprising
obtaining a blood sample said heart failure patient with diastolic dysfunction, measuring by ELISA the concentration of IGFBP2 in said blood sample obtained from said heart failure patient,
comparing the concentration of IGFBP2 measured in said measuring step to a threshold value derived from the concentration of IGFBP2 in blood samples taken from a group of patients wherein each of the patients in the group has stage IV heart failure according to the New York Heart Association (NYHA) heart failure classification system,
readmitting said heart failure patient for further hospitalization if said concentration of IGFBP2 measured in said measuring step exceeds the threshold value, and
administering to said heart failure patient at least one treatment selected from the group consisting of an effective amount of a beta-blocker, an effective amount of an angiotensin-converting enzyme inhibitor, an effective amount of an angiotensin receptor blocker, an effective amount of an aldosterone antagonist, an implantable cardiac defibrillator, a cardiac resynchronization therapy, an implantable left ventricular assistive device and a heart transplant.

### Claim 8 (depends on 1)

The method according to claim 1 wherein said sample is urine.

### Claim 9 (depends on 1)

The method according to claim 1 wherein the group of patient used for deriving said threshold value is derived from a group of patients with stage I heart failure.

### Claim 10 (depends on 1)

The method according to claim 1 wherein the group of patient used for deriving said threshold value is derived from a group of patients with stage II heart failure.

### Claim 11 (depends on 1)

The method according to claim 1 wherein the group of patient used for deriving said threshold value is derived from a group of patients with stage III heart failure.

### Claim 12 (depends on 1)

The method according to claim 1 wherein the group of patient used for deriving said threshold value is derived from a group of patients with stage IV heart failure.

### Claim 13 (depends on 1)

The method of claim 1, wherein the clinical diagnosis of heart failure includes a diagnosis of one or more of chronic heart failure, acute heart failure, myocardial infarction, unstable angina, diastolic dysfunction, systolic dysfunction and diabetic cardiomyopathy.