Methods for treating or predicting risk of a ventricular tachyarrhythmia event

Patent metadata

Field	Value
Publication number	US-11340236-B2
Application number	US-201916563510-A
Country	US
Kind code	B2
Filing date	Sep 6, 2019
Priority date	May 18, 2012
Publication date	May 24, 2022
Grant date	May 24, 2022

Abstract

Provided herein are methods that include (i) determining a level of soluble ST2 in a biological sample from a subject, (i) comparing the level of soluble ST2 in the biological sample to a reference level of soluble ST2 (e.g., a level of soluble ST2 in the subject at an earlier time point), and (iii) selecting, implanting, replacing, or reprogramming an implanted cardiac device, e.g., an ICD, CRT, or CRT-D device, for a subject having an elevated level of soluble ST2 in the biological sample compared to the reference level of soluble ST2, or selecting a subject for participation in, or stratifying a subject participating in, a clinical study of a treatment for reducing the risk of a ventricular tachyarrhythmia (VTA) event. Also provided are methods for evaluating the risk of a VTA event in a subject. Also provided are kits for performing any of these methods.

First claim

What is claimed is:

1. A method for selecting a treatment for a subject having heart failure to reduce the risk of a ventricular tachyarrhythmia (VTA) event, the method comprising:
determining a first level of soluble ST2 in a biological sample comprising blood, serum or plasma obtained from a subject having heart failure at a first time point;
determining a second level of soluble ST2 in a biological sample comprising blood, serum or plasma obtained from the subject at a second time point;
identifying a subject having an elevated second level of soluble ST2 as compared to the first level of soluble ST2 as being more likely to benefit from implantation of an implantable cardiac defibrillator (ICD), a cardiac resynchronization therapy device (CRT), or a combination cardiac resynchronization therapy defibrillator device (CRT-D); and
selecting an ICD, a CRT, or a CRT-D for the identified subject.

2. The method of claim 1 , wherein the subject has previously had at least one ventricular tachyarrhythmia event.

3. The method of claim 1 , wherein the method comprises selecting an ICD for the identified subject.

4. The method of claim 1 , wherein the method comprises selecting a CRT for the identified subject.

5. The method of claim 1 , wherein the method comprises selecting a CRT-D for the identified subject.

6. A method of treating a subject having heart failure to reduce the risk of a ventricular tachyarrhythmia (VTA) event, the method comprising:
determining a first level of soluble ST2 in a biological sample comprising blood, serum, or plasma from a subject having heart failure;
determining a second level of soluble ST2 in a biological sample comprising blood, serum, or plasma from the subject;
identifying a subject having an elevated second level of soluble ST2 in the biological sample compared to the first level of soluble ST2 as being more likely to benefit from implantation of an implantable cardiac defibrillator (ICD), a cardiac resynchronization therapy device (CRT), or a combination cardiac resynchronization therapy defibrillator device (CRT-D); and
implanting an ICD, a CRT, or a CRT-D device into the identified subject, or replacing or reprogramming an implanted ICD, CRT, or CRT-D in the identified subject.

7. The method of claim 6 , wherein the subject has previously had at least one ventricular tachyarrhythmia event.

8. The method of claim 6 , wherein the method comprises implanting an ICD into the identified subject.

9. The method of claim 6 , wherein the method comprises implanting a CRT into the identified subject.

10. The method of claim 6 , wherein the method comprises implanting a CRT-D into the identified subject.

11. The method of claim 6 , wherein the method comprises replacing an implanted ICD in the identified subject.

12. The method of claim 6 , wherein the method comprises replacing an implanted CRT in the identified subject.

13. The method of claim 6 , wherein the method comprises replacing an implanted CRT-D in the identified subject.

14. The method of claim 6 , wherein the method comprises reprogramming an implanted ICD in the identified subject.

15. The method of claim 6 , wherein the method comprises reprogramming an implanted CRT in the identified subject.

16. The method of claim 6 , wherein the method comprises reprogramming an implanted CRT-D in the identified subject.

Assignees

• Critical Care Diagnostics Inc
• Cardiac Pacemakers Inc

Inventors

• Snider James V
• Meyer Timothy Edward
• Stolen Craig Michael
• Gerwien Robert W

Classifications

• G01N33/6893 Primary

  related to diseases not provided for elsewhere · CPC title

• G01N2800/50

  Determining the risk of developing a disease · CPC title

• A61B5/7275

  Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor · CPC title

• G01N33/6887 Primary

  from muscle, cartilage or connective tissue · CPC title

• G01N2800/325

  Heart failure or cardiac arrest, e.g. cardiomyopathy, congestive heart failure · CPC title