OBJECTIVE: To investigate the effect of recombinant human brain natriuretic peptide (rhBNP) on renal function in patients with acute heart failure (AHF) following acute myocardial infarction (AMI). METHODS:Consecutive patients with AHF following AMI were enrolled in this clinical trial. Eligible patients were randomly assigned to receive rhBNP (rhBNP group) or nitroglycerin (NIT group). Patients in the rhBNP group received rhBNP 0.15 μg /kg bolus injection after randomization followed by an adjusted-dose (0.0075-0.020 μg/kg/min) for 72 hours, while patients in NIT received infusion of nitroglycerin with an adjusted-dose (10-100 μg/kg/min) for 72 hours in NIT group. Standard clinical and laboratory data were collected. The levels of serum creatinine (SCr), urea, β-2 microglobulin and cystatin C were measured at baseline and repeated at the end of the 24, 48 and 72 hours after infusion. The primary end point was the incidence of acute renal dysfunction, which was defined as an increase in SCr > 0.5 mg/dl (> 44.2 μmol/L) or 25% above baseline SCr value. The occurrence of major adverse cardiac event (MACE) was followed up for 1 month. RESULTS: Of the 50 patients enrolled, 26 were randomly assigned to rhBNP and 24 to nitroglycerin (NIT). There were no significant differences in baseline characteristics between the two groups (all P > 0.05). The baseline concentrations of SCr, urea, β-2 microglobulin and cystatin C at admission were similar in the two groups. However, the concentrations of SCr and urea were significantly higher in rhBNP group than those in NIT group at hour 24 and 48 after treatments (all P < 0.01). For both groups, the concentrations of SCr, urea, β-2 microglobulin and cystatin C were not significant changed compared with baseline levels. The levels of systolic blood pressure (SBP) and diastolic blood pressures (DBP) at admission were also similar between the two groups. In rhBNP group, levels of SBP and DBP decreased significantly at hour 24, 48 and 72 (all P < 0.05). In NIT group, levels of SBP decreased significantly at hour 48 and 72. The level of SBP at hour 24 and DBP at hour 48 after treatment were lower in rhBNP group than those in NIT group (P < 0.01). The occurrence of MACE was not significantly different. The incidence of acute renal dysfuntion in rhBNP group was higher (9/26 vs. 2/24, P = 0.040). The results of multiple logistic regression found that the use of rhBNP was an independent predictor of acute renal dysfunction in patients with AHF following AMI (OR, 0.162; 95% CI, 0.029 to 0.909; P = 0.039). CONCLUSION: the incidence of acute renal dysfuntion in rhBNP group was higher, and the use of rhBNP was an independent predictor of acute renal dysfunction in patients with AHF following AMI. (ChiCTR-IPR-15005796).
RCT Entities:
OBJECTIVE: To investigate the effect of recombinant human brain natriuretic peptide (rhBNP) on renal function in patients with acute heart failure (AHF) following acute myocardial infarction (AMI). METHODS: Consecutive patients with AHF following AMI were enrolled in this clinical trial. Eligible patients were randomly assigned to receive rhBNP (rhBNP group) or nitroglycerin (NIT group). Patients in the rhBNP group received rhBNP 0.15 μg /kg bolus injection after randomization followed by an adjusted-dose (0.0075-0.020 μg/kg/min) for 72 hours, while patients in NIT received infusion of nitroglycerin with an adjusted-dose (10-100 μg/kg/min) for 72 hours in NIT group. Standard clinical and laboratory data were collected. The levels of serum creatinine (SCr), urea, β-2 microglobulin and cystatin C were measured at baseline and repeated at the end of the 24, 48 and 72 hours after infusion. The primary end point was the incidence of acute renal dysfunction, which was defined as an increase in SCr > 0.5 mg/dl (> 44.2 μmol/L) or 25% above baseline SCr value. The occurrence of major adverse cardiac event (MACE) was followed up for 1 month. RESULTS: Of the 50 patients enrolled, 26 were randomly assigned to rhBNP and 24 to nitroglycerin (NIT). There were no significant differences in baseline characteristics between the two groups (all P > 0.05). The baseline concentrations of SCr, urea, β-2 microglobulin and cystatin C at admission were similar in the two groups. However, the concentrations of SCr and urea were significantly higher in rhBNP group than those in NIT group at hour 24 and 48 after treatments (all P < 0.01). For both groups, the concentrations of SCr, urea, β-2 microglobulin and cystatin C were not significant changed compared with baseline levels. The levels of systolic blood pressure (SBP) and diastolic blood pressures (DBP) at admission were also similar between the two groups. In rhBNP group, levels of SBP and DBP decreased significantly at hour 24, 48 and 72 (all P < 0.05). In NIT group, levels of SBP decreased significantly at hour 48 and 72. The level of SBP at hour 24 and DBP at hour 48 after treatment were lower in rhBNP group than those in NIT group (P < 0.01). The occurrence of MACE was not significantly different. The incidence of acute renal dysfuntion in rhBNP group was higher (9/26 vs. 2/24, P = 0.040). The results of multiple logistic regression found that the use of rhBNP was an independent predictor of acute renal dysfunction in patients with AHF following AMI (OR, 0.162; 95% CI, 0.029 to 0.909; P = 0.039). CONCLUSION: the incidence of acute renal dysfuntion in rhBNP group was higher, and the use of rhBNP was an independent predictor of acute renal dysfunction in patients with AHF following AMI. (ChiCTR-IPR-15005796).
Entities:
Keywords:
Acute heart failure; acute myocardiol infarction; recombinant human brain natriuretic peptide; renal function
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