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Original Investigation |

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

Horng H. Chen, MBBCh1; Kevin J. Anstrom, PhD2; Michael M. Givertz, MD3; Lynne W. Stevenson, MD3; Marc J. Semigran, MD4; Steven R. Goldsmith, MD5; Bradley A. Bart, MD5; David A. Bull, MD6; Josef Stehlik, MD6; Martin M. LeWinter, MD7; Marvin A. Konstam, MD8; Gordon S. Huggins, MD8; Jean L. Rouleau, MD9; Eileen O'Meara, MD9; W. H. Wilson Tang, MD10; Randall C. Starling, MD, MPH10; Javed Butler, MD, MPH11; Anita Deswal, MD12; G. Michael Felker, MD13; Christopher M. O'Connor, MD13; Raphael E. Bonita, MD, ScM14; Kenneth B. Margulies, MD15; Thomas P. Cappola, MD, ScM15; Elizabeth O. Ofili, MD16; Douglas L. Mann, MD17; Víctor G. Dávila-Román, MD17; Steven E. McNulty, MS2; Barry A. Borlaug, MD1; Eric J. Velazquez, MD13; Kerry L. Lee, PhD2; Monica R. Shah, MD, MHS, MSJ18; Adrian F. Hernandez, MD, MHS2; Eugene Braunwald, MD3; Margaret M. Redfield, MD1; for the NHLBI Heart Failure Clinical Research Network
[+] 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.
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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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Figures

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Figure 1.
ROSE Patient Flow Diagram

Data on patients screened for eligibility are not available. The primary end points were analyzed with multiple imputation techniques when data were unavailable for the end point.

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Figure 2.
Dopamine Strategy Subgroup Analysis

Subgroup analysis of treatment effect. A, Cumulative urine volume during 72 hours. B, Change in cystatin C level from baseline to 72 hours with low-dose dopamine vs placebo.

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Figure 3.
Nesiritide Strategy Subgroup Analysis

Subgroup analysis of treatment effect. A, Cumulative urine volume during 72 hours. B, Change in cystatin C level from baseline to 72 hours with low-dose nesiritide vs placebo.

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