Status:
COMPLETED
Human Brain Natriuretic Peptide (BNP) (or Nesiritide) to Help Heart, Kidney and Humoral Function.
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Institutes of Health (NIH)
Scios, Inc.
Conditions:
Left Ventricular Diastolic Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Prior to initiation of the study, subjects will be stabilized for at least one week on a no added salt diet (120 milliequivalent (mEq) Na/Day) which will be maintained during the study. Participants i...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT00405548
Start Date
March 1 2008
End Date
August 1 2012
Last Update
July 1 2015
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905