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Original Investigation
December 18, 2013

Low-Dose Dopamine or Low-Dose Nesiritide in Acute Heart Failure With Renal Dysfunction: The ROSE Acute Heart Failure Randomized Trial

Author Affiliations
  • 1Mayo Clinic, Rochester, Minnesota
  • 2Duke Clinical Research Institute, Durham, North Carolina
  • 3Brigham and Women’s Hospital, Boston, Massachusetts
  • 4Massachusetts General Hospital, Boston
  • 5Hennepin County Medical Center, Minneapolis, Minnesota
  • 6University of Utah, Salt Lake City
  • 7University of Vermont, Burlington
  • 8Tufts Medical Center, Boston, Massachusetts
  • 9University of Montreal and Montreal Heart Institute, Montreal, Canada
  • 10Cleveland Clinic, Cleveland, Ohio
  • 11Emory University, Atlanta, Georgia
  • 12Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas
  • 13Duke University Medical Center and Duke Heart Center, Durham, North Carolina
  • 14Thomas Jefferson University, Philadelphia, Pennsylvania
  • 15University of Pennsylvania, Philadelphia
  • 16Morehouse School of Medicine, Atlanta, Georgia
  • 17Washington University School of Medicine, St Louis, Missouri
  • 18National Heart, Lung, and Blood Institute, Bethesda, Maryland
JAMA. 2013;310(23):2533-2543. doi:10.1001/jama.2013.282190
Abstract

Importance  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 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.

Design, Setting, and Participants  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.

Interventions  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).

Main Outcomes and Measures  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). Similarly, low-dose nesiritide had no significant effect on 72-hour cumulative urine volume (nesiritide, 8574 mL; 95% CI, 8014-9134 vs placebo, 8296mL; 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.

Conclusion and Relevance  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.

Trial Registration  clinicaltrials.gov Identifier: NCT01132846

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