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JAMA. 2013 Dec 18;310(23):2533-43. doi: 10.1001/jama.2013.282190.

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

Collaborators (146)

AbouEzzeddine O, Aguilar D, Alharethi R, Amsler J, Anand I, Bader F, Bart B, Bartolini C, Boddicker K, Bonita R, Borlaug B, Bott-Silverman C, Bove A, Boxer R, Bozkurt B, Bradley J, Budge D, Burelle D, Butler J, Cabral M, Cappola T, Carlson W, Catanzaro J, Chang J, Chen H, Cole R, Craddock H, Davilla V, DeNofrio D, Desai A, Deswal A, Dias A, Ducharme A, Dunbar S, Dunlap M, Ewald G, Fang J, Felker M, Fiorini D, Fitzpatrick J, Florea V, Franco E, Geltman E, Georgiopoulou V, Giannetti N, Gilbert E, Givertz M, Goldberg L, Gonczarek K, Gorodeski E, Gunawardena D, Gupta D, Hanna M, Hardin J, Hobbs R, Holley C, Hsich E, Huggins G, James K, Joseph S, Kalogeropoulous A, Keller A, Kfoury A, Kiernan M, Kociol R, Konstam M, Ky B, Lakdawala N, Lapu-Bula R, Laskar S, Lee S, LeWinter M, Lewis E, Lewis G, Liszkowski M, Mack S, Mapara S, Margulies K, Marti C, Mather P, Meyer M, Meyer T, Miller W, Mills G, Moffa C, Moore S, Mountis M, Movesian M, Movsesian M, Nader S, Nestor M, Newton-Cheh C, Nikolaidis L, Nissley K, Nohria A, Nossuli T, O'Connor C, Oderinde A, Oduwole A, Ofili E, Oliveira G, O'Meara E, Onwuanyi A, Owens A, Parks K, Patel C, Patel A, Prokop K, Quintero Pinzon P, Racine N, Rame J, Rater M, Rathman L, Raza S, Redfield M, Rogers J, Rouleau J, Rubin S, Ruppert L, Saleh N, Saltzberg M, Schilling J, Semigran M, Shih J, Shin J, Sims D, Small R, Smith A, Sorescu D, Starling R, Stehlik J, Stevenson L, Stewart G, Stillabower M, Syros G, Tang W, Taylor D, Thanassoulis G, Tsao L, Udelson J, Vanburen P, Wald J, Wang T, Whellan D, White M, Wick L.

Author information

1
Mayo Clinic, Rochester, Minnesota.
2
Duke Clinical Research Institute, Durham, North Carolina.
3
Brigham and Women's Hospital, Boston, Massachusetts.
4
Massachusetts General Hospital, Boston.
5
Hennepin County Medical Center, Minneapolis, Minnesota.
6
University of Utah, Salt Lake City.
7
University of Vermont, Burlington.
8
Tufts Medical Center, Boston, Massachusetts.
9
University of Montreal and Montreal Heart Institute, Montreal, Canada.
10
Cleveland Clinic, Cleveland, Ohio.
11
Emory University, Atlanta, Georgia.
12
Michael E. DeBakey VA Medical Center and Baylor College of Medicine, Houston, Texas.
13
Duke University Medical Center and Duke Heart Center, Durham, North Carolina.
14
Thomas Jefferson University, Philadelphia, Pennsylvania.
15
University of Pennsylvania, Philadelphia.
16
Morehouse School of Medicine, Atlanta, Georgia.
17
Washington University School of Medicine, St Louis, Missouri.
18
National Heart, Lung, and Blood Institute, Bethesda, Maryland.

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, 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.

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.

PMID:
24247300
PMCID:
PMC3934929
DOI:
10.1001/jama.2013.282190
[Indexed for MEDLINE]
Free PMC Article

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