Division of Cardiology, Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL 60611, USA.
Am Heart J. 2011 Jul;162(1):3-15.e3. doi: 10.1016/j.ahj.2011.03.031.
The development of new therapies for heart failure (HF), especially acute HF, has proven to be quite challenging; and therapies evaluated in HF have greatly outnumbered treatments that are eventually successful in obtaining regulatory approval. Thus, the development of therapies for HF remains a vexing problem for pharmaceutical and device companies, clinical trialists, and health care professionals. Nowhere is this more apparent than in the phase II HF clinical trial, in which the goal is to determine whether an investigational agent should move forward to a phase III trial. Recent advancements in noninvasive cardiovascular imaging have allowed a new era of comprehensive phenotyping of cardiac structure and function in phase II HF trials. Besides using imaging parameters to predict success of subsequent phase III outcome studies, it is essential to also use imaging in phase II HF trials in a way that increases understanding of drug or device mechanism. Determination of the patients who would benefit most from a particular drug or device could decrease heterogeneity of phase III trial participants and lead to more successful HF clinical trials. In this review, we outline advantages and disadvantages of imaging various aspects of cardiac structure and function that are potential targets for therapy in HF, compare and contrast imaging modalities, provide practical advice for the use of cardiovascular imaging in drug development, and conclude with some novel uses of cardiac imaging in phase II HF trials.
心力衰竭（HF）新疗法的发展，尤其是急性心力衰竭的治疗，已被证明极具挑战性；在 HF 中评估的疗法远远超过了最终成功获得监管批准的治疗方法。因此，HF 治疗方法的发展仍然是制药和设备公司、临床试验人员和医疗保健专业人员面临的一个难题。在 HF 二期临床试验中，这一点表现得最为明显，该试验的目的是确定一种新的治疗药物是否应该进入三期临床试验。最近心血管无创成像技术的进步，使得在 HF 二期临床试验中对心脏结构和功能进行全面表型分析成为可能。除了使用成像参数来预测后续三期结果研究的成功之外，在 HF 二期临床试验中，还必须以增加对药物或设备作用机制的理解的方式来使用成像技术。确定最能从特定药物或设备中受益的患者，可以减少三期试验参与者的异质性，从而使 HF 临床试验更成功。在这篇综述中，我们概述了 HF 治疗潜在靶点的心脏结构和功能各方面成像的优缺点，比较和对比了成像方式，为心血管成像在药物开发中的应用提供了实用建议，并总结了心脏成像在 HF 二期临床试验中的一些新用途。
