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Low-dose dopamine or low-dose nesiritide in acute heart failure with renal dysfunction: the ROSE acute heart failure randomized trial.

JAMA (2013-11-20)
Horng H Chen, Kevin J Anstrom, Michael M Givertz, Lynne W Stevenson, Marc J Semigran, Steven R Goldsmith, Bradley A Bart, David A Bull, Josef Stehlik, Martin M LeWinter, Marvin A Konstam, Gordon S Huggins, Jean L Rouleau, Eileen O'Meara, W H Wilson Tang, Randall C Starling, Javed Butler, Anita Deswal, G Michael Felker, Christopher M O'Connor, Raphael E Bonita, Kenneth B Margulies, Thomas P Cappola, Elizabeth O Ofili, Douglas L Mann, Víctor G Dávila-Román, Steven E McNulty, Barry A Borlaug, Eric J Velazquez, Kerry L Lee, Monica R Shah, Adrian F Hernandez, Eugene Braunwald, Margaret M Redfield
ABSTRACT

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. To test the 2 independent hypotheses that, compared with placebo, addition of low-dose dopamine (2 μg/kg/min) or low-dose nesiritide (0.005 μg/kg/min without bolus) to diuretic therapy will enhance decongestion and preserve renal function in patients with acute heart failure and renal dysfunction. 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. Enrollment occurred from September 2010 to March 2013 across 26 sites in North America. Participants were randomized in an open, 1:1 allocation ratio to the dopamine or nesiritide strategy. Within each strategy, participants were randomized in a double-blind, 2:1 ratio to active treatment or placebo. The dopamine (n = 122) and nesiritide (n = 119) groups were independently compared with the pooled placebo group (n = 119). 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). 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). 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). 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. 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. clinicaltrials.gov Identifier: NCT01132846.

MATERIALS
Product Number
Brand
Product Description

Supelco
Dopamine hydrochloride solution, 1.0 mg/mL in methanol with 5% 1 M HCl (as free base), ampule of 1 mL, certified reference material, Cerilliant®
Sigma-Aldrich
Dopamine hydrochloride
Supelco
Dopamine hydrochloride, Pharmaceutical Secondary Standard; Certified Reference Material
Dopamine hydrochloride, European Pharmacopoeia (EP) Reference Standard