PMID- 15809819 OWN - NLM STAT- MEDLINE DCOM- 20051004 LR - 20181113 IS - 1382-4147 (Print) IS - 1382-4147 (Linking) VI - 9 IP - 3 DP - 2004 Jul TI - Treatment with B-type natriuretic peptide for chronic decompensated heart failure: insights learned from the follow-up serial infusion of nesiritide (FUSION) trial. PG - 209-16 AB - 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. FAU - Yancy, Clyde W AU - Yancy CW AD - University of Texas Southwestern Medical Center, Dallas, TX, USA. clyde.yancy@utsouthwestern.edu LA - eng PT - Clinical Trial PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PL - United States TA - Heart Fail Rev JT - Heart failure reviews JID - 9612481 RN - 0 (Natriuretic Agents) RN - 114471-18-0 (Natriuretic Peptide, Brain) SB - IM MH - Aged MH - Chronic Disease MH - Dose-Response Relationship, Drug MH - Drug Administration Schedule MH - Female MH - Follow-Up Studies MH - Heart Failure/*drug therapy MH - Humans MH - Infusions, Intravenous MH - Male MH - Natriuretic Agents/*administration & dosage MH - Natriuretic Peptide, Brain/*administration & dosage MH - Severity of Illness Index MH - Treatment Outcome EDAT- 2005/04/06 09:00 MHDA- 2005/10/05 09:00 CRDT- 2005/04/06 09:00 PHST- 2005/04/06 09:00 [pubmed] PHST- 2005/10/05 09:00 [medline] PHST- 2005/04/06 09:00 [entrez] AID - 10.1007/s10741-005-6132-9 [doi] PST - ppublish SO - Heart Fail Rev. 2004 Jul;9(3):209-16. doi: 10.1007/s10741-005-6132-9.