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CLINICAL RESEARCH: CLINICAL TRIALS

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

Ronald M. Witteles, MD^_*,_*, David Kao, MD^_*, Dianne Christopherson, PhD, RN^_*, Kelly Matsuda, PharmD^_*, Randall H. Vagelos, MD, FACC^_*, Donald Schreiber, MD^, and Michael B. Fowler, MB, FACC^_*

^_* Division of Cardiovascular Medicine, Stanford University School of Medicine, Stanford, California
Department of Emergency Medicine, Stanford University School of Medicine, Stanford, California
Palo Alto Veterans Administration Hospital, Palo Alto, California.

Manuscript received February 12, 2007; revised manuscript received March 26, 2007, accepted March 28, 2007.

^_* Reprint requests and correspondence: Dr. Ronald M. Witteles, Division of Cardiovascular Medicine, Stanford University School of Medicine, 300 Pasteur Drive, Falk CVRC, Stanford, California 94305. (Email: witteles{at}stanford.edu).

Objectives: Our purpose was to evaluate the impact of nesiritide on renal function in patients with acute decompensated heart failure and baseline renal dysfunction.

Background: 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.

Methods: 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 µg/kg/min with or without a 2-µg/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 20% and change in serum creatinine.

Results: 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%).

Conclusions: 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 [ClinicalTrials.gov] )

Abbreviations and Acronyms   ADHF = acute decompensated heart failure   GFR = glomerular filtration rate   IV = intravenous

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