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ASCEND-HF trial - Summary & Results

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http://www.theheart.org/web_slides/1171547.do …

http://www.theheart.org/web_slides/1171547.do

An acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure (ASCEND-HF) with 7141 patients randomized in double-blind fashion within 24 hours of hospitalization and institution of acute IV therapy for ADHF to IV nesiritide or placebo on top of standard therapy

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  • 1. ASCEND-HF (Acute Study of ClinicalEffectiveness of Nesiritide inDecompensated Heart Failure)
  • 2. ASCEND-HF (Acute Study of Clinical Effectiveness ofNesiritide in Decompensated Heart Failure)R Califf (Duke Clinical Research Institute, Durham, NC)American Heart Association 2010 Scientific Sessions• Population and treatment: 7141 patients randomized in double-blind fashion within 24 hours of hospitalization and institution of acute IV therapy for ADHF to IV nesiritide or placebo on top of standard therapy The drug was infused at 0.01 µg/kg/min for up to seven days (at physicians discretion), sometimes preceded (at physicians discretion) by a nesiritide bolus of 2 µg/kg• Co–primary end points: 30-day death/HF hospitalization Dyspnea at 6 hours and 24 hours
  • 3. ASCEND-HF: Results• Nesiritide didnt compromise renal function or increase mortalityResults and renal-function safety end pointOutcome Placebo (n=3511), % Nesiritide (n=3496), % p30-day death/HF hospitalization 10.1 9.4 0.3130-day death 4.0 3.630-day hospitalization 6.1 6.0Dyspnea at 6 h 42.1 44.5 0.030Moderately better 28.7 29.5Markedly better 13.4 15.0Dyspnea at 24 h 66.1 68.2 0.007Moderately better 38.6 37.8Markedly better 27.5 30.4>25% decrease eGFR 29.5 31.4 0.11eGFR=estimated glomerular filtration rate
  • 4. ASCEND-HF: Commentary*"One could achieve similar results with appropriately administered diuretic therapyon top of already-available and appropriate evidence-based medical care." - Dr Clyde W Yancy"These data are very substantial in terms of providing a signal of safety, and onecould argue that that signal is firmer than it is for the other vasodilators." - Dr Keith D Aaronson"We run out of options fast in acute decompensated heart failure." - Dr Mariell Jessup (ASCEND-HF investigator)*All comments from ASCEND-HF: Nesiritide safe but of limited dyspnea benefit in acute HF (http://www.theheart.org/article/1147999.do)
  • 5. Become a member of http://www.theheart.org Become a fan on Facebook: http://www.facebook.com/theheartorg Follow us on Twitter: http://www.twitter.com/theheartorgtheheart.org is the leading online source of independent cardiology news.We are the top provider of news and opinions for over 100 000 physicians.