Acutely Decompensated Heart Failure in a County Emergency Department: A Double-Blind Randomized Controlled Comparison of Nesiritide Versus Placebo Treatment

Study objective: Acutely decompensated congestive heart failure is a major cause of emergency department (ED) visits in county hospitals. This often underserved population has a high rate of return visits to the ED for heart failure. Nesiritide has been demonstrated to relieve symptoms of acutely decompensated congestive heart failure. We examined the effect of an 8-hour infusion of nesiritide on the composite of return to the ED or hospitalization at 30 days. Methods: A prospective, randomized, double-blinded, placebo-controlled trial of nesiritide plus protocol-specified standard therapy versus standard therapy done in the ED for acutely decompensated congestive heart failure. Results: One hundred one patients were randomized during a 16-month enrollment period. Sixty-six percent of the patients were men and 34% were women. Fifty-six percent were black; all patients had New York Heart Association class II to IV heart failure and most had dyspnea at rest or with minimal exertion. Complete follow-up data were available in 97 of 101 patients. After the 8-hour treatment period, acute symptom relief was experienced in 95.7% of the nesiritide group (95% confidence interval [CI] 88.9% to 100%) versus 86.8% of the placebo group (95% CI 72% to 98.9%), with an absolute difference between the 2 groups of 8.9% (95% CI -3.3% to 24.2%). Diuresis was similar between the 2 groups, but hypotension occurred more frequently in the nesiritide-treated group. The primary outcome measure of return visit to the ED or hospitalization at 30 days was higher for nesiritide (41.5%) than placebo (39.6%; absolute difference 1.9%; 95% CI -17.2% to 21.1%). There was only 1 death. No measurable change in renal function was observed. Conclusion: Administration of nesiritide for acutely decompensated congestive heart failure in a county ED was no better than standard therapy alone for return to the ED or hospitalization at 30 days.