Impact of nesiritide on renal function in patients with acute decompensated heart failure and pre-existing renal dysfunction a randomized, double-blind, placebo-controlled clinical trial

• Published in: Journal of the American College of Cardiology 2007-11, Vol.50 (19), p.1835
• Main Authors: Witteles, Ronald M, Kao, David, Christopherson, Dianne, Matsuda, Kelly, Vagelos, Randall H, Schreiber, Donald, Fowler, Michael B
• Format: Article
• Language: English
• Subjects: Acute Kidney Injury - blood; Acute Kidney Injury - drug therapy; Age; Aged; Cardiology; Cardiovascular disease; Chronic obstructive pulmonary disease; Clinical trials; Creatinine - blood; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Drug therapy; Female; Heart failure; Heart Failure - blood; Heart Failure - drug therapy; Humans; Infusions, Intravenous; Injections, Intravenous; Intensive care; Kidney Function Tests; Male; Mortality; Natriuretic Peptide, Brain - administration & dosage; Natriuretic Peptide, Brain - adverse effects; Patients; Pulmonary arteries; Studies
• ISSN: 0735-1097; 1558-3597
• DOI: 10.1016/j.jacc.2007.03.071

Our purpose was to evaluate the impact of nesiritide on renal function in patients with acute decompensated heart failure and baseline renal dysfunction. Although nesiritide is approved for the treatment of acute decompensated heart failure, retrospective analyses have raised concerns that it may cause worsened renal function. To date, no randomized clinical trials have prospectively evaluated this issue. Consecutive patients with acute decompensated heart failure and baseline renal dysfunction were enrolled in this randomized, double-blind, placebo-controlled clinical trial. Subjects were randomized to receive nesiritide (0.01 microg/kg/min with or without a 2-microg/kg bolus) or placebo (5% dextrose in water) for 48 h in addition to their usual care. Predefined primary end points of the trial were a rise in serum creatinine by > or =20% and change in serum creatinine. Seventy-five patients were enrolled (39 nesiritide, 36 placebo). The groups had similar baseline age (74.9 vs. 75.5 years, respectively), blood pressure (123/64 vs. 125/64 mm Hg) and serum creatinine (1.82 vs. 1.86 mg/dl). There were no significant differences in the incidence of a 20% creatinine rise (23% vs. 25%) or in the change in serum creatinine (-0.05 vs. +0.05 mg/dl). There were no significant differences in the secondary end points of change in weight (-2.19 vs. -1.58 kg), intravenous furosemide (125 vs. 107 mg), discontinuation of the infusion due to hypotension (13% vs. 6%), or 30-day death/hospital readmission (33% vs. 25%). In this randomized, double-blind, placebo-controlled clinical trial, nesiritide had no impact on renal function in patients with acute decompensated heart failure. (BNP-CARDS trial; http://www.clinicaltrials.gov/ct/show/NCT00186329?order=1; NCT00186329).