Method of testing for heart failure risk

• US 5,498,524 A
• Filed: 01/25/1994
• Issued: 03/12/1996
• Est. Priority Date: 03/12/1993
• Status: Expired due to Term

• Current Assignee: Medinnova S.F.
• Original Assignee: Medinnova S.F.
• Inventors: Hall, Christian
• Primary Examiner(s): Woodward, Michael P.
• Assistant Examiner(s): STUCKER, JEFFREY J
• Application Number:
  US08/186,680
• Time in Patent Office: 777 Days
• Field of Search: 436/518, 436/542, 436/501, 436/811, 436/536, 436/539, 435/7.1, 435/7.9, 435/7.92, 435/7.93, 435/7.95, 435/975, 530/350, 530/388.24, 530/389.2
• US Class Current: 435/7.1
• CPC Class Codes: G01N 2333/58 Atrial natriuretic factor complex; Atriopeptin; Atrial natriuretic peptide [ANP]; Brain natriuretic peptide [BNP, proBNP]; Cardionatrin; Cardiodilatin
• CPC Class Codes: G01N 33/74 involving hormones or other non-cytokine intercellular protein regulatory factors such as growth factors, including receptors to hormones and growth factors
• CPC Class Codes: Y10S 436/811 Test for named disease, body condition or organ function

Abstract

The peptide N-terminal pro-ANF, which is present in body fluids such as plasma, has been found to be an effective predictor of heart failure and the invention provides prediction and screening methods based upon in vitro assaying of N-terminal pro-ANF in body fluids.

Claims

1. A method of testing for heart failure risk in an asymptomatic patient, which comprises contacting a body fluid sample from the asymptomatic patient with an antibody which specifically binds to N-terminal Pro-ANF and detecting the formation of an immune complex by immunoassay, and comparing the peptide level thus obtained to control levels as an indication of said risk.

3. A method as claimed in claim 1 or claim 2 wherein said human is selected from humans over 70 years of age, humans exhibiting hypertension and humans having or having previously had a form of heart disease.

4. A method as claimed in claim 1 or 2 wherein said body fluid comprises plasma.

5. A method as claimed in claim 4 wherein a plasma level of higher than 1500 pmols N-terminal pro-ANF/L plasma is taken as indicative of risk of development of heart failure.

6. A method as claimed in claim 1 or claim 2 wherein said body fluid comprises plasma.

7. A method as claimed in claim 6 wherein a plasma level of higher than 1500 pmols N-terminal pro-ANF/l plasma is taken as indicative of risk of development of heart failure.

8. A method as claimed in claim 1 or claim 2, wherein the level of N-terminal pro-ANF is determined.

9. A method as claimed in claim 1 or claim 2, wherein an immunoassay is performed using an antibody raised against N-terminal pro-ANF.

10. The method of claim 1 wherein said contacting step is conducted using components from a kit comprising

(a) an antibody which specifically binds to N-terminal pro-ANF, and at least one of the following;

(b) a labeled sample of N-terminal pro-ANF;

(c) an antibody, as defined in (a), in non-immobilized form;

or

(d) a labeled secondary antibody specific to said antibody (c).

2. A method of screening asymptomatic patients, either for risk of developing heart failure, or lack thereof, which comprises contacting a body fluid sample from the asymptomatic patient with an antibody which specifically binds to N-terminal Pro-ANF and detecting the formation of an immune complex by immunoassay, and assessing the patient'"'"'s risk of developing heart failure upon the basis of said levels.

11. The method of claim 2 wherein said contacting step is conducted using components from a kit comprising

(a) an antibody which specifically binds to N-terminal pro-ANF, and at least one of the following;

(b) a labeled sample of N-terminal pro-ANF;

(c) an antibody, as defined in (a), in non-immobilized form;

or

(d) a labeled secondary antibody specific to said antibody (c).