Renal Optimization Strategies Evaluation in Acute Heart Failure - ROSE AHF
The goal of the trial was to evaluate treatment with low-dose dopamine or low-dose nesiritide compared with placebo among patients with acute heart failure and renal dysfunction.
Low-dose dopamine and/or low-dose nesiritide will improve outcomes.
- Placebo Controlled
- Patients with acute heart (≥1 symptom of dyspnea, orthopnea, or edema) and (≥1 sign of rales, edema, ascites, pulmonary edema on chest X-ray) regardless of ejection fraction
- Enrolled within 24 hours of hospital admission
- Estimated glomerular filtration rate 15-60 ml/min/1.73 m2
Number of enrollees: 360 patients
Duration of follow-up: mean 180 days
Mean patient age: 70 years
Percentage female: 25%
Ejection fraction: 30% (median)
- Cumulative urinary volume at 72 hours
- Change in cystatin-C at 72 hours
- Change in weight
- Change in N-terminal pro–B-type natriuretic peptide (NT-proBNP)
- Change in creatinine
- Cardiorenal syndrome
- Drug tolerance
- Adverse events
Patients with acute heart failure and renal dysfunction were randomized to low-dose dopamine (2 µg/kg/min; n = 122), versus low-dose nesiritide (0.005 µg/kg/min without bolus; n = 119), versus placebo (n = 119).
Patients received standard background diuretic therapy.
Overall, 360 patients were randomized. The mean age was 70 years, 25% were female, mean body mass index was 31 kg/m2, ischemic etiology was present in 61%, 56% had diabetes, mean systolic blood pressure was 116 mm Hg, and median ejection fraction was 30%.
Low-dose dopamine: The co-primary outcome of 72-hour urine volume was 8.5 L in the dopamine group versus 8.3 L in the placebo group (p = 0.58). Patients with ejection fraction ≤50% appeared to derive more benefit from dopamine (p for interaction = 0.01).
The co-primary outcome of change in cystatin-C was 0.12 mg/L in the dopamine group versus 0.11 mg/dl in the placebo group (p = 0.72).
Death, unscheduled office visit, or heart failure admission at 60 days was similar between groups (p = 0.53). Death at 180 days was also similar between groups (p = 0.87).
Low-dose nesiritide: The co-primary outcome of 72-hour urine volume was 8.6 L in the nesiritide group versus 8.3 L in the placebo group (p = 0.25). Patients with ejection fraction ≤50% appeared to derive more benefit from nesiritide (p for interaction 0.06).
The co-primary outcome of change in cystatin-C was 0.07 mg/L in the nesiritide group versus 0.11 mg/dl in the placebo group (p = 0.35).
Death, unscheduled office visit, or heart failure admission at 60 days was similar between groups (p = 0.16). Death at 180 days was also similar between groups (p = 0.74).
Among patients with acute heart failure and renal dysfunction, neither low-dose dopamine nor low-dose nesiritide enhanced decongestion or improved renal function. These findings differ from results of previous small studies. Nesiritide and dopamine are used in a significant proportion of heart failure patients, and in the case of dopamine, recommended by heart failure guidelines. The use of these agents will likely need to be re-evaluated in the setting of acute heart failure and renal dysfunction.
Chen HH, Anstrom KJ, Givertz MM, et al., on behalf of the NHLBI Heart Failure Clinical Research Network. Low-Dose Dopamine or Low-Dose Nesiritide in Acute Heart Failure With Renal Dysfunction: The ROSE Acute Heart Failure Randomized Trial. JAMA 2013;310:2533-43.
Presented by Dr. Horng H. Chen at the American Heart Association Scientific Sessions, Dallas, TX, November 18, 2013.
Keywords: Body Mass Index, Diuretics, Heart Failure, Blood Pressure, Dopamine, Systole, Diabetes Mellitus, Cystatin C, Natriuretic Peptide, Brain
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