Status:
TERMINATED
Nesiritide in Chronic Heart Failure
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
Scios, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to look at the safety and effectiveness of longer term intravenous (IV) infusion of the study drug, nesiritide in patients with acutely decompensated chronic heart failure...
Detailed Description
This is a single center, double-blinded, crossover, placebo-controlled pilot study to evaluate the effects of nesiritide in patients with chronic heart failure. This study will only take place at the ...
Eligibility Criteria
Inclusion
- Candidates for enrollment in this clinical trial are limited to adult patients (age\>21) diagnosed with chronic heart failure \> one year who are managed by heart failure specialists at the University of Chicago. Patients primarily managed by physicians other than the investigators will be enrolled with the concurrence of the treating physician. Study patients are characterized as "high risk" by fulfilling one or more of the following criteria:
- Refractory class III or IV heart failure despite optimal medical therapy by a heart failure specialist: Angiotensin converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARB), beta-adrenergic blockers (BB), spironolactone (spiro), digoxin (dig), diuretics, and calcium channel blockers (CCB).
- Frequent hospitalizations or ER visits (\>1/month on average).
- Additionally, patients must be capable of giving informed consent and have adequate social supports to manage chronic, continuous IV infusion therapy with the assistance of home care nursing and the study coordinator.
Exclusion
- Nesiritide infusion \>24 hours in the previous 30 days.
- Stable chronic heart failure or NYHA Class I or II.
- Aortic stenosis greater than mild degree as determined by echocardiogram or catheterization.
- Hypertrophic cardiomyopathy with an outflow tract gradient.
- Isolated right heart failure (cor pulmonale).
- Unstable coronary syndrome or myocardial infarction\< 3 months prior to enrollment.
- Chronic hypotension with systolic blood pressure \< 80 mmHg.
- Terminal noncardiovascular illness with life expectancy \<6 months. Moribund patients will not be considered for enrollment.
- Active substance abuse.
- Inadequate social support.
- Contraindication to long term IV access.
- Pregnant or lactating females.
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
September 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00145873
Start Date
August 1 2003
End Date
September 1 2006
Last Update
October 8 2013
Active Locations (1)
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1
University of Chicago Hospitals
Chicago, Illinois, United States, 60637