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

1. ASCEND-HF (Acute Study of Clinical
Effectiveness of Nesiritide in
Decompensated Heart Failure)

2. ASCEND-HF (Acute Study of Clinical Effectiveness of
Nesiritide 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 physician's
discretion), sometimes preceded (at physician's 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 didn't compromise renal function or increase mortality
Results and renal-function safety end point
Outcome Placebo (n=3511), % Nesiritide (n=3496), % p
30-day death/HF hospitalization 10.1 9.4 0.31
30-day death 4.0 3.6
30-day hospitalization 6.1 6.0
Dyspnea at 6 h 42.1 44.5 0.030
Moderately better 28.7 29.5
Markedly better 13.4 15.0
Dyspnea at 24 h 66.1 68.2 0.007
Moderately better 38.6 37.8
Markedly better 27.5 30.4
>25% decrease eGFR 29.5 31.4 0.11
eGFR=estimated glomerular filtration rate

4. ASCEND-HF: Commentary*
"One could achieve similar results with appropriately administered diuretic therapy
on 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 one
could 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)

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