AIM: To examine the effect of the beta(1)-selective beta-blocker nebivolol, administered as add-on therapy, on left ventricular function in 260 elderly patients (>65 years) with chronic heart failure (CHF). METHODS: The principal inclusion criteria were (1) NYHA class II-IV CHF and (2) a left ventricular ejection fraction (LVEF) <= 35%. The primary end-point was the change in LVEF in response to nebivolol treatment for 8 months. RESULTS:Baseline LVEF values in the two groups were as follows: nebivolol 25.41+/-7.09% and control 26.41+/-5.55%. LVEF improved significantly (p=0.027) more in the nebivolol group (6.51+/-9.15%) than in the control group (3.97+/-9.20%), the relative improvement (percentage increase in the initial value) being 35.70+/-57.62% in the nebivolol group and 19.19+/-40.96% (p=0.008) in the placebo group. Examination of different subgroups did not reveal any heterogeneity in the effects of nebivolol treatment vs. placebo treatment. There were no significant differences between the nebivolol and placebo groups as concerns the changes in clinical status, quality of life, or safety parameters. CONCLUSION: The findings of the ENECA study confirmed that nebivolol significantly improved cardiac function and proved to be safe and well tolerated in elderly patients with signs of CHF and an impaired LVEF.
RCT Entities:
AIM: To examine the effect of the beta(1)-selective beta-blocker nebivolol, administered as add-on therapy, on left ventricular function in 260 elderly patients (>65 years) with chronic heart failure (CHF). METHODS: The principal inclusion criteria were (1) NYHA class II-IV CHF and (2) a left ventricular ejection fraction (LVEF) <= 35%. The primary end-point was the change in LVEF in response to nebivolol treatment for 8 months. RESULTS: Baseline LVEF values in the two groups were as follows: nebivolol 25.41+/-7.09% and control 26.41+/-5.55%. LVEF improved significantly (p=0.027) more in the nebivolol group (6.51+/-9.15%) than in the control group (3.97+/-9.20%), the relative improvement (percentage increase in the initial value) being 35.70+/-57.62% in the nebivolol group and 19.19+/-40.96% (p=0.008) in the placebo group. Examination of different subgroups did not reveal any heterogeneity in the effects of nebivolol treatment vs. placebo treatment. There were no significant differences between the nebivolol and placebo groups as concerns the changes in clinical status, quality of life, or safety parameters. CONCLUSION: The findings of the ENECA study confirmed that nebivolol significantly improved cardiac function and proved to be safe and well tolerated in elderly patients with signs of CHF and an impaired LVEF.
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