Cardiac Hormone Replacement With Brain Natriuretic Peptide (BNP) in Heart Failure

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effects of subcutaneous injection of Human BNP (nesiritide), a hormone produced by the heart, on the pumping ability of the heart, kidney function, and hormonal function in persons with heart failure.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Horng Chen
• Collaborators: American Heart Association; National Center for Research Resources (NCRR); National Heart, Lung, and Blood Institute (NHLBI); Scios, Inc.
• Treatments: Hormones; Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

1. Age > 18 years

2. Resting left ventricular ejection fraction (LVEF) of 35% or less (determined within 48 months of recruitment by echocardiography, multiple gate acquisition scan (MUGA) or left ventriculogram.)

3. New York Heart Association (NYHA) Class I (with previous symptoms of heart failure), Class II and III

4. Female subjects not menopausal or surgically sterilized will need to have a negative pregnancy test the day before the study day and be on contraception.

Exclusion Criteria:

1. Myocardial infarction (MI) within 3 months of screening.

2. Unstable angina within 14 days of screening, or any evidence of myocardial ischemia.

3. Valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis.

4. Sustained ventricular tachycardia (VT) or ventricular fibrillation (V-fib) within 14 days of screening.

5. Second or third degree atrioventricular (AV) block without a permanent cardiac pacemaker.

6. Cerebrovascular accident (CVA) within 3 months of screening, or other evidence of significantly compromised central nervous system (CNS) perfusion.

7. Serum creatinine of >3.0 mg/dL.

8. Serum sodium of <125 milliequivalents per decaLiter (mEq/dL) or > 160 mEq/dL.

9. Serum potassium of < 3.5 mEq/dL or > 5.2 mEq/dL.

10. Serum digoxin level of > 2.0 ng/ml.

11. Systolic pressure of <85 mmHg immediately prior to the first injection of study drug/placebo.

12. LVEF > 35% by within 24 months of screening.

13. Unable to self-administer subcutaneous injection twice a day.

14. Diagnosed with AIDS or known positive HIV titer.

15. Other acute or chronic medical conditions or laboratory abnormality, which may increase the risks, associated with study participation or may interfere with interpretation of the data.

16. Received an investigational drug within 1 month prior to dosing.

17. Unable to undergo cardiac magnetic resonance imaging (MRI). Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial fibrillation or other arrhythmia, cerebral aneurysm clips, or severe claustrophobia.

18. In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons.

19. Patient in atrial fibrillation or who have a pacemaker or implantable cardioverter defibrillator (ICD)

20. Hemoglobin < 10g/dl.

21. Patients with an allergy to iodine.