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ROSE AHF: Dopamine, nesiritide did not improve kidney function in acute HF patients
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DALLAS — Low doses of dopamine and nesiritide did not benefit kidney function in patients with acute HF, according to late-breaking clinical trial data presented at AHA 2013.
Both drugs had shown promise for improving renal function and decongestion in smaller previous studies, but those findings were not confirmed in the randomized, double blind, placebo-controlled ROSE AHF trial, Horng H. Chen, MD, of Mayo Clinic, said during a press conference.
Horng H. Chen
Chen and colleagues enrolled 360 patients (median age, 70 years; 27% women) hospitalized for acute HF who had renal dysfunction, defined as glomerular filtration rate of 15 mL/min/1.73m2 to 60 mL/min/1.73m2. Patients were assigned 2 mcg/kg/min dopamine (n=122), 0.005 mcg/kg/min nesiritide without bolus (n=119) or placebo (n=119), in addition to optimal diuretic dosing.
The primary endpoints were change in serum cystatin-C at 72 hours and cumulative urine volume at 72 hours.
Compared with placebo, low-dose dopamine had no effect on cumulative urine volume at 72 hours (dopamine, 8,524 mL; 95% CI, 7,917-9,131; placebo, 8,296 mL; 95% CI, 7,762-8,830; difference, 229 mL; 95% CI, –714 to 1,171; P=.59) or on changes in cystatin-C level (dopamine, 0.12 mg/L; 95% CI, 0.06-0.18; placebo, 0.11 mg/L; 95% CI, 0.06-0.16; difference, 0.01; 95% CI, −0.08 to 0.1; P=.72).
There was a suggestion that dopamine had a differential effect on cumulative urine volume at 72 hours in patients with HF and reduced ejection fraction compared with those with preserved EF (P for interaction=.01), according to Chen. There was no difference between those assigned dopamine and those assigned placebo in rates of 60-day death, unscheduled visit or readmission for HF (HR=1.15; 95% CI, 0.74-1.78), or 180-day mortality (HR=0.95; 95% CI, 0.54-1.68).
Compared with placebo, low-dose nesiritide had no effect on cumulative urine volume at 72 hours (nesiritide, 8,574 mL; 95% CI, 8,014-9,034; placebo, 8,296 mL; 95% CI, 7,762-8,830; difference, 279 mL; 95% CI, –618 to 1,176; P=.49) or on changes in cystatin-C level (nesiritide, 0.07 mg/L; 95% CI, 0.01-0.13; placebo, 0.11 mg/L; 95% CI, 0.06-0.16; difference, –0.04; 95% CI, −0.13 to 0.05; P=.36).
There was a nonsignificant trend suggesting that nesiritide had a differential effect on cumulative urine volume at 72 hours and change in cystatin C in patients with HF and reduced ejection fraction compared with those with preserved EF (P for interaction=.06 and .09, respectively). There was no significant difference between those assigned nesiritide and those assigned placebo in rates of 60-day death, unscheduled visit or readmission for HF (HR=0.71; 95% CI, 0.44-1.15), or 180-day mortality (HR=0.91; 95% CI, 0.51-1.61).
“Future investigations of these or other acute HF therapies may need to assess the potential for differential responses in HF and preserved vs. reduced ejection fraction,” Chen said at the press conference. – by Erik Swain
For more information:
Chen HH. LBCT.03. Medical and surgical approaches to improving heart failure outcomes. Presented at: the American Heart Association Scientific Sessions; Nov. 16-20, 2013; Dallas.
Chen HH. JAMA. 2013;doi:10.1001/jama.2013.282190.
Disclosure: Chen reports an ownership interest in Zumbro Discovery, royalty income from Anexon, Niles Therapeutics and Up-to-Date, and grant income from Scios.
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Mark A. Creager, MD, FACC
I think this was an incredibly important trial. I commend the NHLBI Heart Failure Clinical Research Network for undertaking it. It should impact our care of patients with acute HF and compromised renal function in this way: We need to be less impulsive about pulling drugs off the shelf that we thought were effective, but now we find are not. This should help guide physicians in what they should do — and importantly, what they should not do — in most patients who have acute HF and compromised kidney function.
It demonstrates the importance of a well-done, controlled clinical trial. It gives us the evidence that we need to make informed practice decisions. In this case, it was a negative trial, but an important negative trial.
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