Greenberg Barry H, Mehra Mandeep, Teerlink John R, Ordronneau Paul, McCollum David, Gilbert Edward M
Department of Medicine, University of California San Diego Medical Center, San Diego, California 92103-8411, USA.
Am J Cardiol. 2006 Oct 2;98(7A):53L-59L. doi: 10.1016/j.amjcard.2006.08.003. Epub 2006 Aug 28.
Left ventricular ejection fraction (LVEF) is an important measure of ventricular function in the evaluation of heart failure. Immediate-release (IR) carvedilol twice daily has been shown to improve LVEF in subjects with ischemic and nonischemic chronic heart failure. A once-daily formulation, controlled-release (CR) carvedilol, is expected to improve quality of care through improved adherence as a result of the reduced frequency of dosing. This multicenter, randomized, double-blind study in subjects with stable chronic heart failure will compare the change in LVEF in patients receiving carvedilol IR with those receiving carvedilol CR. LVEF will be measured by 2-dimensional echocardiography at 6 months after entry into the maintenance period of the study drug. The secondary objectives of this study are to assess changes in left ventricular remodeling and function, to evaluate changes in brain natriuretic peptide levels, and to determine the incidence of all-cause and heart failure-related hospitalizations and all-cause mortality after treatment with carvedilol CR or carvedilol IR.
左心室射血分数(LVEF)是评估心力衰竭时心室功能的一项重要指标。已证明,每日两次服用速释型(IR)卡维地洛可改善缺血性和非缺血性慢性心力衰竭患者的LVEF。每日一次的控释型(CR)卡维地洛制剂,预计可通过减少给药频率提高依从性,从而改善护理质量。这项针对稳定型慢性心力衰竭患者的多中心、随机、双盲研究,将比较接受IR卡维地洛的患者与接受CR卡维地洛的患者LVEF的变化。在进入研究药物维持期6个月后,将通过二维超声心动图测量LVEF。本研究的次要目标是评估左心室重构和功能的变化,评估脑钠肽水平的变化,并确定接受CR卡维地洛或IR卡维地洛治疗后全因住院和心力衰竭相关住院的发生率以及全因死亡率。