Am J Cardiol. 1990 Aug 1;66(3):315-22. doi: 10.1016/0002-9149(90)90842-o.
The Studies of Left Ventricular Dysfunction (SOLVD) is an extensive program of research that has 3 components. (1) Two large double-blind randomized trials evaluate the effects of enalapril on mortality, morbidity and quality of life of patients with left ventricular (LV) dysfunction with overt congestive heart failure (CHF) (Treatment Trial in 2,500 patients) and without overt CHF (Prevention Trial in 4,600 patients). (2) Seven detailed sub-studies evaluate the effect of enalapril on a number of intermediate outcomes such as right and LV function and hemodynamics, LV mass and wall stress, hormones, arrhythmias, exercise capacity and quality of life in subsets of patients in the 2 large trials. (3) Finally, a registry of 6,336 patients with congestive heart failure or LV dysfunction is designed to describe the clinical course of an unselected group of patients. The rationale and design of a tiered approach to clinical trials that are large enough to provide reliable information on mortality and morbidity, yet provide relevant information on other endpoints, are described.
左心室功能障碍研究（SOLVD）是一项广泛的研究计划，包括三个部分。（1）两项大型双盲随机试验评估依那普利对伴有明显充血性心力衰竭（CHF）的左心室（LV）功能障碍患者（2500例患者的治疗试验）和无明显CHF的患者（4600例患者的预防试验）的死亡率、发病率和生活质量的影响。（2）七项详细的子研究评估依那普利对一些中间结局的影响，如右心室和左心室功能及血流动力学、左心室质量和壁应力、激素、心律失常、运动能力和生活质量，这些研究针对两项大型试验中部分患者子集进行。（3）最后，设计了一个包含6336例充血性心力衰竭或左心室功能障碍患者的登记系统，以描述一组未经挑选患者的临床病程。本文描述了一种分层临床试验方法的基本原理和设计，该方法规模足够大，能够提供关于死亡率和发病率的可靠信息，同时也能提供关于其他终点的相关信息。
