[Efficacy and safety of intravenous recombinant human brain natriuretic peptide in patients with decompensated acute heart failure: a multicenter, randomized, open label, controlled study].

OBJECTIVE: To explore the safety of intravenous recombinant human brain natriuretic peptide (rhBNP) in treating acute decompensated heart failure and acute exacerbation of chronic heart failure, and to compare the differences in efficacy with different dosage and administration time. METHODS: A total of 2160 patients characterized of acute decompensated heart failure and acute exacerbation of chronic heart failure were enrolled in this multicenter, randomized, open, dose-control study. The patients were randomly allocated to four groups with different doses and administration time on top of standard therapy. RESULTS: In the safety respect, the rate of hypotension is 1.44% at 5 - 7 days after treatment, the serum creatinine level was reduced compared to baseline (P values were 0.0437, 0.0087 and 0.0116) except in the group of 0.015 µg at 24 h (P = 0.7054). The rate of 30-day readmission is 5.65%, mortality rate is 9.44%. In terms of efficacy, dyspnea was significantly improved at 30 min after administration, and at 24 h after administration (all P < 0.01). Urine output and LEVF were also significantly increased by 76.59% (P < 0.01) and 12.08% respectively (all P < 0.01) compared to baseline. Plasma NT-proBNP decreased by 40.29% at 5 - 7 days after administration (P < 0.01). CONCLUSION: The clinical application of intravenous rhBNP is safe and effective for treatment of acute decompensated heart failure and acute exacerbation of chronic heart failure in this large patient cohort.