Cardiac Hormone Replacement With Brain Natriuretic Peptide (BNP) in Heart Failure
NCT ID: NCT00252187
Last Updated: 2012-12-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
45 participants
INTERVENTIONAL
2000-01-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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B-type Natriuretic Peptide (BNP)
BNP (nesiritide) administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
B-type Natriuretic Peptide (BNP)
BNP hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
Placebo
Placebo self-administered subcutaneously twice daily for 8 weeks.
Placebo
Placebo self-administered subcutaneously twice daily for 8 weeks.
Interventions
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B-type Natriuretic Peptide (BNP)
BNP hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
Placebo
Placebo self-administered subcutaneously twice daily for 8 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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American Heart Association
OTHER
Scios, Inc.
INDUSTRY
National Heart, Lung, and Blood Institute (NHLBI)
NIH
National Center for Research Resources (NCRR)
NIH
Horng Chen
OTHER
Responsible Party
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Horng Chen
MD, Professor of Medicine
Principal Investigators
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Horng H. Chen, M.D.
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Countries
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References
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Chen HH, Glockner JF, Schirger JA, Cataliotti A, Redfield MM, Burnett JC Jr. Novel protein therapeutics for systolic heart failure: chronic subcutaneous B-type natriuretic peptide. J Am Coll Cardiol. 2012 Dec 4;60(22):2305-12. doi: 10.1016/j.jacc.2012.07.056. Epub 2012 Nov 1.
Other Identifiers
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69-00
Identifier Type: -
Identifier Source: org_study_id