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Means and methods for diagnosing and/or treating a subject at risk of developing heart failure

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Means and methods for diagnosing and/or treating a subject at risk of developing heart failure


The present invention relates to a method for identifying a subject at risk of developing heart failure, comprising: (a) determining the level of one or more biological markers in a biological sample of the subject; (b) comparing the level of the biological marker to a standard level of the same biological marker; and (c) determining whether the level of the marker is indicative of a risk for developing heart failure, wherein the biological marker is Krüppel-Like Factor 15 (KLF-15) and/or lysosomal integral membrane protein-2 (LIMP-2) and/or fragments and/or variants thereof, and/or wherein the biological marker is a gene coding for KLF 15 and/or LIMP-2, and/or fragments and/or variants thereof. The invention further relates to use of the KLF15 and/or LIMP-2 protein, and/or the gene coding for KLF15 and/or LIMP2, and/or fragments, and/or variants of the genes and/or proteins, for the preparation of a medicament for a prophylactic and/or a therapeutic medicament for prevention and/or treatment of heart failure.

Inventors: Yigal M. Pinto, Esther E. Creemers, Joost L. Leenders
USPTO Applicaton #: #20120270244 - Class: 435 792 (USPTO) - 10/25/12 - Class 435 
Chemistry: Molecular Biology And Microbiology > Measuring Or Testing Process Involving Enzymes Or Micro-organisms; Composition Or Test Strip Therefore; Processes Of Forming Such Composition Or Test Strip >Involving Antigen-antibody Binding, Specific Binding Protein Assay Or Specific Ligand-receptor Binding Assay >Assay In Which An Enzyme Present Is A Label >Heterogeneous Or Solid Phase Assay System (e.g., Elisa, Etc.)

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The Patent Description & Claims data below is from USPTO Patent Application 20120270244, Means and methods for diagnosing and/or treating a subject at risk of developing heart failure.

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CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No. 12/440,226, filed Aug. 25, 2009, now U.S. Pat. No. 8,153,376, issued Apr. 10, 2012, which is a national phase entry of PCT/EP2007/060173, filed Sep. 25, 2007, and published in English as International Patent Publication WO 2008/037720 A2 on Apr. 3, 2008, which claims the benefit under Article 8 of the Patent Cooperation Treaty to European Patent Application Serial No. 06121196.7, filed Sep. 25, 2006, and European Patent Application Serial No. 06121525.7, filed Sep. 29, 2006, the disclosure of each of the above-referenced priority documents is hereby incorporated herein by this reference in its entirety.

TECHNICAL FIELD

The present invention, in general, relates to the field of medicine, more specifically, the field of cardiology. The invention, in particular, relates to means and methods for diagnosing and/or treating subjects at risk of developing heart failure.

BACKGROUND

It is generally known that chronic cardiac loading, as occurs during long-standing hypertension, valvular disease or other chronic disorders like diabetes, induces cardiac hypertrophy, which is one of the most important risk factors for heart failure. Congestive heart failure (HF) is a common but severe and complex clinical syndrome, especially among elderly people, characterized by a diminished cardiac contractile function and decreased exercise tolerance. Symptoms of heart failure include, amongst others, pulmonary and peripheral edema, fatigue and/or dyspnea. Severe heart failure may also lead to reduced function in other organs because these are not receiving enough blood.

Not all hypertrophied hearts, however, will ultimately fail. Thus, while an important number of patients progress to developing life-threatening complications, others may remain stable for prolonged periods. Until now, the molecular changes that precede and herald this transition from hypertrophy towards heart failure are incompletely understood.

As early identification of patients at risk for developing hypertensive end organ damage, such as heart failure, may prevent rapid progression, it would be preferable to be able to identify (diagnose) those patients in which heart failure is likely to occur before it actually does so. Early diagnosed patients may thus be treated in order to prevent the onset of heart failure. In addition, it would be preferable to be able to identify those patients suffering from heart failure who are at risk for developing severe complications.

Current methods can reliably exclude the actual presence of heart failure, but cannot reliably prove the existence of heart failure, nor can these methods predict the outcome of established heart failure, or predict the occurrence of heart failure.

A need, therefore, exists for simple and reliable methods for predicting the likelihood of onset of heart failure and/or for predicting the outcome of already established heart failure. In addition, the development of means and methods for treating patients who are at risk of developing heart failure, before heart failure and/or its complications occur, would be of great clinical importance.

DISCLOSURE

The object of the present invention is to provide diagnostic methods by which patients can be identified who are at particular risk of developing heart failure and/or who are at particular risk to develop complications of heart failure. It is a further object of the present invention to provide means and methods for treating patients who are at risk of developing heart failure and/or who are at risk for developing complications of heart failure.

This objective is achieved by the present invention by providing a method for diagnosing a subject at risk of developing heart failure, comprising the steps of: (a) determining the level of one or more biological markers in a biological sample of the subject; (b) comparing the level of the biological marker(s) to a standard level of the same biological marker(s); and (c) determining whether the level of the biological marker(s) is indicative of a risk for developing heart failure, wherein the biological marker is lysosomal integral membrane protein-2 (LIMP-2) and/or Krüppel-Like Transcription Factor 15 (KLF15).

In the research that led to the present invention, a number of genes have been identified that are involved in the development of heart failure. The identified genes have been listed in Table 2. It has furthermore been demonstrated that specific polypeptides encoded by the genes are indeed mechanistically linked to heart failure. It has, in particular, been demonstrated that specific proteins encoded by the genes from Table 2 are involved in the molecular mechanisms that are responsible for the transition from cardiac hypertrophy towards heart failure, and thus can be used as a biological marker for identifying patients at risk of developing heart failure. In addition, these proteins, and/or the genes encoding these proteins, and/or polypeptide and/or polynucleotide fragments or variants of these proteins and/or genes, can be used as a target for treating those patients at risk.

According to the present invention, it has, in particular, been demonstrated that specific intercalated disc components, in particular, lysosomal integral membrane protein-2 (LIMP-2) and Krüppel-Like Transcription Factor 15 (KLF15) are involved in the molecular mechanisms that predict the transition from cardiac hypertrophy towards heart failure, and can suitably be used as biological markers (biomarkers) for the identification of individuals who are at risk of developing heart failure.



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stats Patent Info
Application #
US 20120270244 A1
Publish Date
10/25/2012
Document #
13413536
File Date
03/06/2012
USPTO Class
435/792
Other USPTO Classes
436501, 435 29, 435/71
International Class
01N33/566
Drawings
16



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