Renal Optimization Strategies Evaluation in Acute Heart Failure - ROSE AHF

Nov 18, 2013
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
National Heart, Lung, and Blood Institute; National Center for Advancing Translational Sciences; and the National Institute on Minority Health and Health Disparities
Date Presented:
01/01/2013
Date Published:
01/01/2013
Date Updated:
11/18/2013
Original Posted Date:
11/18/2013
References

Description:

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.

Hypothesis:

Low-dose dopamine and/or low-dose nesiritide will improve outcomes.

Study Design

  • Placebo Controlled
  • Randomized
  • Parallel
  • Stratified

Patient Populations:

  • 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)

Primary Endpoints:

  • Cumulative urinary volume at 72 hours
  • Change in cystatin-C at 72 hours

Secondary Endpoints:

  • Change in weight
  • Change in N-terminal pro–B-type natriuretic peptide (NT-proBNP)
  • Change in creatinine
  • Cardiorenal syndrome
  • Drug tolerance
  • Adverse events

Drug/Procedures Used:

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.

Principal Findings:

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).

Interpretation:

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.

References:

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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