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

NCT00252187 | Completed Phase 1 Results DMC

• 5 other identifiers: 69-00R01HL036634R01HL084155P01HL076611UL1RR024150
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congestive Heart Failure; Cardiomyopathy

Keywords

Heart failure; Natriuretic peptides; B-type natriuretic peptide; Kidney; Nesiritide; Natrecor; CHF

Outcome Measures

Primary Outcomes (2)

• Change in Left Ventricular (LV) Volume Index at 8 Weeks

  LV volume was measured for systolic volume and diastolic volume using a cardiac Magnetic Resonance Imaging (MRI) scan. All cardiac MRI images were reviewed by an independent cardiologist in a blinded fashion.

  Baseline and 8 weeks

• Change in Left Ventricular (LV) Mass Index at 8 Weeks

  Baseline and 8 weeks

Secondary Outcomes (6)

• Change in Left Ventricular (LV) Filling Pressure at 8 Weeks

  Baseline and 8 weeks

• Change in Plasma Renin Activity at 8 Weeks

  Baseline and 8 weeks

• Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) at 8 Weeks

  Baseline and 8 weeks

• Change in Heart Rate at 8 Weeks

  Baseline and 8 weeks

• Change in Blood Pressure at 8 Weeks

  Baseline and 8 weeks

Study Arms (2)

B-type Natriuretic Peptide (BNP)

ACTIVE COMPARATOR

BNP (nesiritide) administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.

Drug: B-type Natriuretic Peptide (BNP)

Placebo

PLACEBO COMPARATOR

Placebo self-administered subcutaneously twice daily for 8 weeks.

Other: Placebo

Interventions

B-type Natriuretic Peptide (BNP) DRUG

BNP hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.

Also known as: Nesiritide

B-type Natriuretic Peptide (BNP)

Placebo OTHER

Placebo self-administered subcutaneously twice daily for 8 weeks.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• 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.)
• New York Heart Association (NYHA) Class I (with previous symptoms of heart failure), Class II and III
• 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.

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.
• Valvular stenosis, hypertrophic, restrictive or obstructive cardiomyopathy, constrictive pericarditis, primary pulmonary hypertension, or biopsy proven active myocarditis.
• Sustained ventricular tachycardia (VT) or ventricular fibrillation (V-fib) within 14 days of screening.
• Second or third degree atrioventricular (AV) block without a permanent cardiac pacemaker.
• Cerebrovascular accident (CVA) within 3 months of screening, or other evidence of significantly compromised central nervous system (CNS) perfusion.
• Serum creatinine of \>3.0 mg/dL.
• Serum sodium of \<125 milliequivalents per decaLiter (mEq/dL) or \> 160 mEq/dL.
• Serum potassium of \< 3.5 mEq/dL or \> 5.2 mEq/dL.
• Serum digoxin level of \> 2.0 ng/ml.
• Systolic pressure of \<85 mmHg immediately prior to the first injection of study drug/placebo.
• LVEF \> 35% by within 24 months of screening.
• Unable to self-administer subcutaneous injection twice a day.
• Diagnosed with AIDS or known positive HIV titer.
• 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.

Sponsors & Collaborators

• Horng Chen: lead
• American Heart Association: collaborator
• Scios, Inc.: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• National Center for Research Resources (NCRR): collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 23122795 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies

Interventions

Natriuretic Peptide, Brain

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Results Point of Contact

• Title: Dr. Horng H. Chen
• Organization: Mayo Clinic

chen.horng@mayo.edu

507-778-2354

Study Officials

• Horng H. Chen, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, Professor of Medicine

Study Record Dates

• First Submitted: November 10, 2005
• First Posted: November 11, 2005
• Study Start: January 1, 2000
• Primary Completion: July 1, 2008
• Study Completion: June 1, 2010
• Last Updated: December 20, 2012
• Results First Posted: December 20, 2012

Record last verified: 2012-12

Locations

US (1)