Phase 2
N=45
Cardiac Hormone Replacement With Brain Natriuretic Peptide (BNP) in Heart Failure
Congestive Heart Failure · Cardiomyopathy
Bottom Line
View on ClinicalTrials.gov: NCT00252187 ↗Enrolled (actual)
45
Serious AEs
8.9%
Results posted
Dec 2012
Primary outcome: Primary: Change in Left Ventricular (LV) Volume Index at 8 Weeks — -5.2; 5.8; -10.0; 6.1 ml/m^2 — p=0.004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- B-type Natriuretic Peptide (BNP) (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Horng Chen
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Left Ventricular (LV) Volume Index at 8 Weeks |
-5.2; 5.8; -10.0; 6.1 | 0.004 sig |
| PRIMARY Change in Left Ventricular (LV) Mass Index at 8 Weeks |
-4.4; 6.2 | 0.006 sig |
| SECONDARY Change in Left Ventricular (LV) Filling Pressure at 8 Weeks |
-2.3; 1.1 | 0.001 sig |
| SECONDARY Change in Plasma Renin Activity at 8 Weeks |
-3.5; 2.3 | — |
| SECONDARY Change in Renal Function as Measured by Glomerular Filtration Rate (GFR) at 8 Weeks |
6.9; -2.8 | 0.14 |
| SECONDARY Change in Heart Rate at 8 Weeks |
-1.6; -0.9 | — |
| SECONDARY Change in Blood Pressure at 8 Weeks |
-4.9; 4.5; -2.4; 0.9 | — |
| SECONDARY Change in Left Ventricular Ejection Fraction at 8 Weeks |
0.0; -1.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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 160 mEq/dL.
- Serum potassium of 5.2 mEq/dL.
- Serum digoxin level of > 2.0 ng/ml.
- Systolic pressure of 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.
- Received an investigational drug within 1 month prior to dosing.
- 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.
- In the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any reasons.
- Patient in atrial fibrillation or who have a pacemaker or implantable cardioverter defibrillator (ICD)
- Hemoglobin < 10g/dl.
- Patients with an allergy to iodine.
Data sourced from ClinicalTrials.gov (NCT00252187). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.