Document Detail


Treatment with B-type natriuretic peptide for chronic decompensated heart failure: insights learned from the follow-up serial infusion of nesiritide (FUSION) trial.
MedLine Citation:
PMID:  15809819     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
Several evidence-based treatment regimens are modestly effective in patients with moderately severe to severe heart failure, but truly effective therapies that improve symptoms, reduce hospitalizations, and extend meaningful survival do not exist for these patients. Only ventricular replacement therapy, with either heart transplantation or left ventricular assist devices, has been shown to significantly improve outcomes. Nesiritide, a recombinant B-type natriuretic peptide, is associated with significant reductions in filling pressure, with corresponding relief of symptoms, and diminished neurohormonal levels and has no inotropic effects and no evidence of proarrhythmia when given to patients with decompensated acute heart failure. Results of the Follow-Up Serial Infusion of Nesiritide (FUSION) trial suggest that a regimen incorporating nesiritide can be accomplished with a reasonable assurance of safety and tolerability; pre-study concerns regarding hypotension were not realized. A qualified look at outcomes data within FUSION I suggests that further study of this paradigm is reasonable, especially if the studied patient population includes patients with a low left ventricular ejection fraction and New York Heart Association (NYHA) class III disease with renal insufficiency, or patients with low left ventricular ejection fraction and NYHA class IV heart failure. Therefore, FUSION II, a double-blind, placebo-controlled trial, will randomly assign approximately 900 such patients to treatment with usual care plus nesiritide or usual care plus placebo and will use mortality/cardiorenal hospitalization as a composite end point. If positive data emerge from FUSION II that either confirm or strengthen the data in FUSION I, a new therapeutic option may be available for patients with chronic decompensated heart failure.
Authors:
Clyde W Yancy
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Heart failure reviews     Volume:  9     ISSN:  1382-4147     ISO Abbreviation:  Heart Fail Rev     Publication Date:  2004 Jul 
Date Detail:
Created Date:  2005-04-05     Completed Date:  2005-10-04     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9612481     Medline TA:  Heart Fail Rev     Country:  United States    
Other Details:
Languages:  eng     Pagination:  209-16     Citation Subset:  IM    
Affiliation:
University of Texas Southwestern Medical Center, Dallas, TX, USA. clyde.yancy@utsouthwestern.edu
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MeSH Terms
Descriptor/Qualifier:
Aged
Chronic Disease
Dose-Response Relationship, Drug
Drug Administration Schedule
Female
Follow-Up Studies
Heart Failure / drug therapy*
Humans
Infusions, Intravenous
Male
Natriuretic Agents / administration & dosage*
Natriuretic Peptide, Brain / administration & dosage*
Severity of Illness Index
Treatment Outcome
Chemical
Reg. No./Substance:
0/Natriuretic Agents; 114471-18-0/Natriuretic Peptide, Brain

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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