Boden W E, Ziesche S, Carson P E, Conrad C H, Syat D, Cohn J N
Cardiology Section, the Veterans Affairs Medical Center, Boston, Massachusetts, USA.
Am J Cardiol. 1996 May 15;77(12):1078-82. doi: 10.1016/s0002-9149(96)00136-1.
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.
血管紧张素转换酶抑制剂和非选择性血管扩张剂（肼屈嗪和硝酸异山梨酯）治疗已成为有症状的慢性充血性心力衰竭（CHF）患者的公认治疗方法，并且在大型临床试验中已证明可改善症状、提高运动能力并降低心脏死亡率。然而，CHF患者的管理仍然是一项治疗挑战。第二项血管扩张剂 - 心力衰竭试验（V-HeFT II）表明，依那普利治疗的平均2年死亡率（18%）显著低于肼屈嗪 - 硝酸异山梨酯治疗（25%），但有点令人惊讶的是，非特异性血管扩张剂在运动能力和左心室功能方面的改善明显更多。这些数据表明，使用单一类别的血管扩张剂治疗可能无法改善症状、血流动力学和生存率，但通过联合使用不同药物可能会使其达到最佳效果。本报告描述了V-HeFT III的基本原理和设计，这是一项多中心、前瞻性、随机、双盲、安慰剂对照试验，比较每日两次口服2.5至5毫克慢性缓释非洛地平（非洛地平ER），在添加到依那普利和袢利尿剂的稳定治疗方案中，无论有无地高辛，对纽约心脏协会功能分级为II至III级的CHF患者进行至少12周随访时，对运动能力、发病率和死亡率的影响。非洛地平是一种第二代二氢吡啶类钙拮抗剂，具有高度的血管选择性，在本研究使用的剂量下，通过降低外周血管阻力发挥其全身动脉作用，而不会产生负性肌力作用。V-HeFT III的结果可能会为加用血管扩张剂治疗在CHF患者管理中的作用提供重要线索。
