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首页> 外文期刊>Journal of cardiac failure >Rationale and design of the enoximone clinical trials program.
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Rationale and design of the enoximone clinical trials program.

机译：依诺酮临床试验计划的原理和设计。

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BACKGROUND: Chronic heart failure is a disease syndrome characterized in its advanced stages by a poor quality of life, frequent hospitalizations, and a high risk of mortality. In advanced and ultra-advanced chronic heart failure, many treatment options, such as cardiac transplantation and mechanical devices, are severely limited by availability and cost. Short-term Phase II clinical trials suggest that low-dose oral inotropic therapy with enoximone may improve hemodynamics and exercise capacity, without adversely affecting mortality, in selected subjects with advanced chronic heart failure. Based on these data, the ability of enoximone to deliver safe and efficacious palliative treatment of advanced/ultra-advanced chronic heart failure is being evaluated in Phase III clinical trials. METHODS AND RESULTS: The Enoximone Clinical Trials Program is a series of 4 clinical trials designed to evaluate the safety and efficacy of oral enoximone in advanced chronic heart failure. ESSENTIAL I and II (The Studiesof Oral Enoximone Therapy in Advanced Heart Failure) will investigate the effects of oral enoximone on all-cause mortality and cardiovascular hospitalization, submaximal exercise capacity, and quality of life in subjects with New York Heart Association Class III/IV chronic heart failure. EMOTE (Oral Enoximone in Intravenous Inotrope-Dependent Subjects) will evaluate the potential of oral enoximone to wean subjects with ultra-advanced chronic heart failure from chronic intravenous inotropic therapy to which they have been shown to be dependent. EMPOWER (Enoximone Plus Extended-Release Metoprolol Succinate in Subjects with Advanced Chronic Heart Failure) will explore the potential of enoximone to increase the tolerability of continuous release metoprolol in subjects shown previously to be hemodynamically intolerant to beta-blocker treatment. CONCLUSION: These studies are Phase III, multicenter, randomized, double-blinded, placebo-controlled trials designed to test the general hypothesis that chronic oral administration of low doses of enoximone can produce beneficial effects in subjects with advanced or ultra-advanced chronic heart failure.
机译：背景：慢性心力衰竭是一种疾病综合征，其特征是生活质量差，经常住院和死亡风险高。在晚期和超高级慢性心力衰竭中，许多治疗选择（例如心脏移植和机械设备）受到可用性和成本的严重限制。短期的II期临床试验表明，对于某些患有慢性慢性心力衰竭的患者，用Enoximone进行低剂量口服正性肌力疗法可以改善血液动力学和运动能力，而不会不利地影响死亡率。基于这些数据，III期临床试验正在评估依诺西酮提供安全有效的姑息治疗晚期/超前性慢性心力衰竭的能力。方法和结果：Enoximone临床试验计划是一系列4项临床试验，旨在评估口服Enoximone在晚期慢性心力衰竭中的安全性和有效性。基本I和II（晚期心力衰竭的口服依诺酮治疗方法的研究）将研究口服依诺酮对纽约心脏协会III / IV级受试者全因死亡率和心血管疾病住院，次最大运动能力以及生活质量的影响慢性心力衰竭。 EMOTE（静脉依托剂依赖型患者中的口服依诺西酮）将评估口服依诺西酮治疗已证实依赖的慢性静脉正性肌力疗法使患有超高级慢性心力衰竭的受试者断奶的潜力。 EMPOWER（在患有慢性慢性心力衰竭的受试者中使用Enoximone Plus缓释琥珀酸美托洛尔琥珀酸酯）将探索Enoximone增强连续释放美托洛尔对先前表现出对β受体阻滞剂血液动力学不耐受的受试者的耐受性的潜力。结论：这些研究是III期，多中心，随机，双盲，安慰剂对照试验，旨在检验以下一般性假设：长期口服低剂量的依诺酮可对患有晚期或超晚期慢性心力衰竭的受试者产生有益作用。

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