Status:
COMPLETED
Human B-type Natriuretic Peptide (BNP) (Nesiritide) to Help Heart, Kidney, and Hormonal Functions in Persons With Lower Heart Pumping Function
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
National Center for Research Resources (NCRR)
Conditions:
Heart Failure
Asymptomatic Systolic Dysfunction
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The following are done for screening procedures to determine if patients are eligible for this study: blood count, kidney and liver blood tests. Patients will complete a 6-minute walk test. Patients w...
Detailed Description
Participants in this study will be randomized to receive BNP or placebo (an inactive, saline shot). The participant will need to give themselves a shot in their stomach (similar to diabetics giving th...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects with an ejection fraction of less than 45%
- No clinical signs or symptoms of congestive heart failure
- Ability to walk a minimal distance of \> 450 meters on a 6-minute walk. If the subject is not able to walk 450 meters due to pain in hips and knees and not fatigue or shortness of breath, they will still qualify for the protocol.
- The subjects will all be on stable doses of an angiotensin converting enzyme (ACE) inhibitor for two weeks prior to the active study date.
- Therapy with other vasodilators, beta-receptor antagonists, digoxin and antiarrhythmic medications will be allowed, however, all medications must be at stable doses two weeks prior to the study date.
- Exclusion criteria:
- Myocardial infarction 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
- Serum creatinine of \> 3.0 mg/dL
- Serum sodium of \< 125 milliequivalent (mEq)/dL or \> 160 mEq/dL
- Serum potassium of \< 3.5 mEq/dL or \> 5.0 mEq/dL change to 5.3
- Serum digoxin level of \> 2.0 ng/ml
- Systolic pressure of \< 85 mmHg
- Hemoglobin \< 10 gm/dl
Exclusion
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00405639
Start Date
June 1 2006
End Date
May 1 2013
Last Update
March 17 2014
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905