Therapy with angiotensin-converting enzyme inhibitors and nonselective vasodilators (hydralazine and isosorbide dinitrate) has become accepted treatment in patients with symptomatic, chronic congestive heart failure (CHF), and has been demonstrated in large clinical trials to ameliorate symptoms, improve exercise performance, and reduce cardiac mortality. Nevertheless, the management of patients with CHF remains a therapeutic challenge. The second Vasodilator-Heart Failure Trial (V-HeFT II) showed that the average 2-year mortality with enalapril (18%) was significantly lower than that with hydralazine-isosorbide dinitrate (25%) but, somewhat surprisingly, the nonspecific vasodilators produced significantly more improvement in exercise performance and left ventricular function. Such data suggest that improvement in symptoms, hemodynamics, and survival may not be afforded by the use of a single class of vasodilator therapy, but might be optimized by the combined use of different agents. This report describes the rationale and design of V-HeFT III, a multicenter, prospective, randomized, double-blind, placebo-controlled trial comparing the effects of chronic oral extended-release felodipine (felodipine ER) 2.5 to 5 mg twice daily, when added to a stable regimen of enalapril and loop diuretics, with or without digoxin, on exercise performance, morbidity, and mortality in patients with New York Heart Association functional class II to III CHF followed for a minimum of 12 weeks. Felodipine is a second-generation dihydropyridine calcium antagonist with a high degree of vascular selectivity which, in the doses used in this study, exerts its systemic arterial effect by decreasing peripheral vascular resistance without producing negative inotropic effects. The results of V-HeFT III may shed important light on the role of additive vasodilator therapy in the management of patients with CHF.

译文

血管紧张素转换酶抑制剂和非选择性血管扩张剂(肼苯哒嗪和硝酸异山梨酯)的治疗已成为有症状,慢性充血性心力衰竭(CHF)患者的公认治疗方法,并且已在大型临床试验中证明其可改善症状,改善运动表现并降低心脏死亡率。然而,CHF患者的治疗仍然是治疗上的挑战。第二项血管扩张剂心脏衰竭试验(V-HeFT II)表明,依那普利(2%)的平均2年死亡率显着低于二氢肼屈嗪-异山梨醇酯(25%),但令人惊讶的是,产生了非特异性血管扩张剂显着改善运动表现和左心室功能。这些数据表明,使用单类血管扩张剂治疗可能无法改善症状,血液动力学和存活率,但可以通过组合使用不同的药物来优化症状,血液动力学和存活率。本报告介绍了V-HeFT III的原理和设计,该研究是一项多中心,前瞻性,随机,双盲,安慰剂对照试验,比较了慢性口服缓释非洛地平(非洛地平ER)2.5至5 mg每天两次的效果,当时在有心脏心脏功能衰竭的纽约心脏协会II级至III级CHF患者中,将其加入稳定的依那普利和loop利尿剂治疗方案(有或没有地高辛)对运动表现,发病率和死亡率的影响,持续至少12周。非洛地平是第二代二氢吡啶类钙拮抗剂,具有高度的血管选择性,在本研究中使用的剂量,可通过降低周围血管阻力而发挥系统性动脉效应,而不会产生负性变力作用。 V-HeFT III的结果可能会进一步阐明加性血管扩张剂治疗在CHF患者治疗中的作用。

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