Kleber F X, Reindl I, Wenzel M, Rodewyk P, Beil S, Kosloswki B, Doering W, Sabin G V, Hinzmann S, Winter U J
Herz. 1993 Dec;18 Suppl 1:424-9.
Left ventricular damage by necrosis of myocardial tissue can lead to compromise of left ventricular function, to left ventricular volume increase and ultimately to development of heart failure. This sequence in the pathophysiology has been shown to be blunted by ACE inhibitors. Volume increase, however, can also be helpful in restoring stroke volume and ameliorate elevation of filling pressures. Furthermore, very early institution of ACE inhibition has failed to improve short-term mortality after myocardial infarction in one large trial. The aim of the ECCE trial therefore is, to investigate the early effects of the ACE inhibitor captopril on compromise of exercise capacity, thought to be a first measurable sign of developing heart failure. The ECCE trial is a randomized, seven-center investigation, studying the effects of ACE inhibition on oxygen uptake in a double blind, placebo controlled design in a group of 204 patients. Sample size was calculated on the basis of a pilot trial. The study design and first not unblinded data of 104 patients are presented. The population consists of predominantly male patients with mostly first myocardial infarction. They were admitted to hospital within five hours of onset of chest pain. End-diastolic volumes were normal, but ejection fraction was moderately compromised. ACE inhibition was started after the first day, but within 72 hours of onset of chest pain. After four and after twelve weeks, oxygen uptake was considerably below expected values and one third of the patients had severe compromise of exercise capacity.(ABSTRACT TRUNCATED AT 250 WORDS)
心肌组织坏死导致的左心室损伤可致使左心室功能受损、左心室容积增加,并最终发展为心力衰竭。病理生理学中的这一过程已被证实可被血管紧张素转换酶(ACE)抑制剂所抑制。然而,容积增加也有助于恢复每搏输出量并减轻充盈压升高。此外,在一项大型试验中,极早期使用ACE抑制剂未能改善心肌梗死后的短期死亡率。因此,ECCE试验的目的是研究ACE抑制剂卡托普利对运动能力受损的早期影响,运动能力受损被认为是心力衰竭发展的首个可测量迹象。ECCE试验是一项随机、多中心研究,采用双盲、安慰剂对照设计,研究ACE抑制对204例患者摄氧量的影响。样本量是根据一项预试验计算得出的。本文介绍了该研究设计以及104例患者首次未设盲的数据。研究对象主要为男性患者,大多为首次发生心肌梗死。他们在胸痛发作后5小时内入院。舒张末期容积正常,但射血分数中度受损。ACE抑制剂在胸痛发作后的第一天开始使用,但在72小时内。在4周和12周后,摄氧量显著低于预期值,三分之一的患者运动能力严重受损。(摘要截选至250字)