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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Left Ventricular Diastolic Dysfunction

In brief

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.

Key facts

Study ID

NCT00405548

Run by

Mayo Clinic

People needed

41

Starts

2008-03-01

Expected to finish

2012-08-01

Last updated by the study team

2015-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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