Human Brain Natriuretic Peptide (BNP) (or Nesiritide) to Help Heart, Kidney and Humoral Function.

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to evaluate the effects of cardiac hormone replacement with SQ (subcutaneous or under the skin) injection of BNP (brain natriuretic peptide, a hormone produced by the heart) on the pumping ability of the heart, kidney function and levels of different hormones in the blood in response to an intravenous salt solution.

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

Details

• Lead Sponsor: Mayo Clinic
• Collaborators: National Center for Research Resources (NCRR); National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH); Scios, Inc.
• Treatments: Natriuretic Peptide, Brain

Criteria

Inclusion Criteria:

• Subjects with ejection fraction of greater than 50% with moderate or severe diastolic dysfunction as assessed by Doppler echocardiography

• No signs or symptoms of congestive heart failure and who have not been hospitalized for heart failure

Exclusion criteria:

• Myocardial Infarction (MI) within 3 months of screening

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

• Significant valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis

• Severe congenital heart diseases

• Sustained ventricular tachycardia or ventricular fibrillation within 14 days of screening

• Second or third degree heart block without a permanent cardiac pacemaker

• Stroke within 3 months of screening, or other evidence of significantly compromised central nervous system (CNS) perfusion

• Total bilirubin of > 1.5 mg/dL or other liver enzymes > 1.5 times the upper limit of normal (mg/dL = milligrams per deciliter)

• Serum creatinine of > 3.0 mg/dL

• Serum sodium of < 125 mEq/dL or > 160 mEq/dL (milliequivalents per deciliter)

• Serum potassium of < 3.5 mEq/dL or > 5.0/dL

• Serum digoxin level of > 2.0 ng/ml (nanograms per milliliter)

• Systolic pressure of < 85 mm Hg (millimeters of mercury)

• Hemoglobin < 10 gm/dl (grams per deciliter)