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OBJECTIVE	Small studies suggest that low-dose dopamine or low-dose nesiritide may enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction ; however , neither strategy has been rigorously tested .
OBJECTIVE	To test the 2 independent hypotheses that , compared with placebo , addition of low-dose dopamine ( 2 g/kg/min ) or low-dose nesiritide ( 0.005 g/kg/min without bolus ) to diuretic therapy will enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction .
METHODS	Multicenter , double-blind , placebo-controlled clinical trial ( Renal Optimization Strategies Evaluation [ ROSE ] ) of 360 hospitalized patients with acute heart failure and renal dysfunction ( estimated glomerular filtration rate of 15-60 mL/min/1 .73 m2 ) , randomized within 24 hours of admission .
METHODS	Enrollment occurred from September 2010 to March 2013 across 26 sites in North America .
METHODS	Participants were randomized in an open , 1:1 allocation ratio to the dopamine or nesiritide strategy .
METHODS	Within each strategy , participants were randomized in a double-blind , 2:1 ratio to active treatment or placebo .
METHODS	The dopamine ( n = 122 ) and nesiritide ( n = 119 ) groups were independently compared with the pooled placebo group ( n = 119 ) .
METHODS	Coprimary end points included 72-hour cumulative urine volume ( decongestion end point ) and the change in serum cystatin C from enrollment to 72 hours ( renal function end point ) .
RESULTS	Compared with placebo , low-dose dopamine had no significant effect on 72-hour cumulative urine volume ( dopamine , 8524 mL ; 95 % CI , 7917-9131 vs placebo , 8296 mL ; 95 % CI , 7762-8830 ; difference , 229 mL ; 95 % CI , -714 to 1171 mL ; P = .59 ) or on the change in cystatin C level ( dopamine , 0.12 mg/L ; 95 % CI , 0.06-0 .18 vs placebo , 0.11 mg/L ; 95 % CI , 0.06-0 .16 ; difference , 0.01 ; 95 % CI , -0.08 to 0.10 ; P = .72 ) .
RESULTS	Similarly , low-dose nesiritide had no significant effect on 72-hour cumulative urine volume ( nesiritide , 8574 mL ; 95 % CI , 8014-9134 vs placebo , 8296 mL ; 95 % CI , 7762-8830 ; difference , 279 mL ; 95 % CI , -618 to 1176 mL ; P = .49 ) or on the change in cystatin C level ( nesiritide , 0.07 mg/L ; 95 % CI , 0.01-0 .13 vs placebo , 0.11 mg/L ; 95 % CI , 0.06-0 .16 ; difference , -0.04 ; 95 % CI , -0.13 to 0.05 ; P = .36 ) .
RESULTS	Compared with placebo , there was no effect of low-dose dopamine or nesiritide on secondary end points reflective of decongestion , renal function , or clinical outcomes .
CONCLUSIONS	In participants with acute heart failure and renal dysfunction , neither low-dose dopamine nor low-dose nesiritide enhanced decongestion or improved renal function when added to diuretic therapy .
BACKGROUND	clinicaltrials.gov Identifier : NCT01132846 .

