奈必洛尔与卡维地洛对老年射血分数保留的心衰患者左心室舒张功能的比较效果：一项随机对照试验的研究方案
Comparative effects of nebivolol and carvedilol on left ventricular diastolic function in older heart failure patients with preserved ejection fraction: study protocol for a randomized controlled trial.
作者信息
Park Kyungil, Park Tae-Ho
机构信息
Division of Cardiology, Department of Internal Medicine, Dong-A University College of Medicine, 1 Dongdae-sin-dong 3-ga, Seo-gu, Busan, 602-715, South Korea.
出版信息
Trials. 2016 Nov 3;17(1):530. doi: 10.1186/s13063-016-1656-y.
BACKGROUND
Heart failure (HF) is a common and disabling condition in older people. Randomized clinical trials and meta-analyses have clearly demonstrated that the long-term use of β-Blockers improves the outcome of patients with HF. However, limited data are available on the treatment of older HF patients with preserved ejection fraction (EF). No study has specifically compared the relative effectiveness of carvedilol and nebivolol in treating HF in older patients with preserved EF.
METHOD/DESIGN: This trial is a prospective, randomized, open-label, single-centre, active controlled study designed to investigate the effects of nebivolol and carvedilol on diastolic function of the left ventricle (LV) in older HF patients with preserved EF. We will test the hypothesis that nebivolol improves LV diastolic function to a greater extent than carvedilol in patients over 70 years of age. The study population includes 62 older patients newly diagnosed with HF. Patients will be included in the study if they have a LVEF ≥40 %, New York Heart Association (NYHA) functional classes I, II or III status, and have been clinically stable without hospital admission for HF in the preceding 3 months. Eligible patients will be randomly assigned, in a 1:1 ratio, to receive a loading and maintenance dose of either nebivolol or carvedilol. Echocardiographic evaluations will be performed at baseline, 6, and 12 months after therapy. Clinical assessment and laboratory tests are to be performed at fixed times.
DISCUSSION
This trial is a single-center study that aims to evaluate the impact of nebivolol on LV diastolic function. The results of the study will provide information about the optimal choice of a β-Blocker in the management of patients after diagnosis of HF with preserved EF. The results will be available by 2017.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02619526 , registered on 25 November 2015.
背景
心力衰竭（HF）在老年人中是一种常见且使人衰弱的病症。随机临床试验和荟萃分析已明确表明，长期使用β受体阻滞剂可改善HF患者的预后。然而，关于射血分数（EF）保留的老年HF患者的治疗数据有限。尚无研究专门比较卡维地洛和奈必洛尔在治疗EF保留的老年患者HF方面的相对疗效。
方法/设计：本试验是一项前瞻性、随机、开放标签、单中心、活性对照研究，旨在研究奈必洛尔和卡维地洛对EF保留的老年HF患者左心室（LV）舒张功能的影响。我们将检验这样一个假设：在70岁以上的患者中，奈必洛尔比卡维地洛能更大程度地改善LV舒张功能。研究人群包括62例新诊断为HF的老年患者。如果患者左心室射血分数（LVEF）≥40%、纽约心脏协会（NYHA）心功能分级为I、II或III级，且在过去3个月内临床稳定且未因HF住院，将被纳入研究。符合条件的患者将按1:1的比例随机分配，接受奈必洛尔或卡维地洛的负荷剂量和维持剂量。治疗后在基线、6个月和12个月时进行超声心动图评估。临床评估和实验室检查将在固定时间进行。
讨论
本试验是一项单中心研究，旨在评估奈必洛尔对LV舒张功能的影响。研究结果将提供有关在诊断为EF保留的HF患者管理中β受体阻滞剂最佳选择的信息。结果将于2017年公布。
试验注册
ClinicalTrials.gov标识符：NCT02619526，于2015年11月25日注册。
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