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Nesiritide in Chronic Heart Failure

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clinicaltrials.gov/study/NCT00145873
Is a
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Clinical study
0

Clinical Study attributes

NCT Number
NCT001458730
Health Conditions in Trial
Heart failure
Heart failure
0
Trial Recruitment Size
200
Trial Sponsor
University of Chicago
University of Chicago
0
Clinical Trial Start Date
2003
0
Primary Completion Date
2006
0
Study Completion Date
2006
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Interventional Trial Phase
Phase 20
Official Name
Continuous Infusion Nesiritide in Chronic Heart Failure-University of Chicago (CINCH-UC)0
Last Updated
October 8, 2013
0
Allocation Type
Randomized0
Intervention Model
Crossover Assignment0
Masking Type
Double0
Study 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. Nesiritide (Natrecor) is a man-made version of a human hormone that dilates veins and arteries. Nesiritide (Natrecor) is currently FDA-approved for short-term inpatient IV treatment of acutely decompensated chronic heart failure. Hypothesis: Nesiritide, administered by continuous intravenous infusion in the outpatient setting, is a safe treatment for refractory Class III \& IV chronic heart failure due to systolic or diastolic dysfunction, regardless of renal function when administered over a 12-week period. Corollary #1: Nesiritide, when infused continuously over 12 weeks will improve the overall condition of patients with chronic heart failure. These mechanisms include reducing hospitalizations when compared with the previous six months, improving symptoms as measured by the Minnesota Living with Heart Failure short questionnaire, and improving functional capacity as measured by 6-minute walk testing. Corollary #2: Nesiritide infusion will be associated with a statistically significant decrease in N-terminal pro-BNP levels and cyclic GMP levels compared with patients receiving placebo infusions.

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