Protocol for a randomized controlled trial of intensive blood pressure control on cardiovascular risk reduction in patients with atrial fibrillation: Rationale and design of the CRAFT trial

IF 3.7 2区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS

American heart journal Pub Date : 2024-09-07 DOI:10.1016/j.ahj.2024.08.008

Chao Jiang MD , Zhiyan Wang MD , Xin Du MD, PhD , Yufeng Wang MD , Mingyang Gao MD , Zhaoxu Jia MD , Zhongyi Chai MD , Zhiyun Yang MD , Chi Wang PhD , Liu He PhD , Rong Hu MD , Qiang Lv MD , Jiahui Wu MD , Xu Li MD , Changqi Jia MD , Rong Han ME , Hisatomi Arima MD, PhD , Xia Wang PhD , Bruce Neal MD, PhD , Anthony Rodgers MD, PhD , Changsheng Ma MD

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引用次数: 0

Abstract

Background

Co-morbid hypertension is strong predictor of adverse cardiovascular (CV) outcomes in patients with atrial fibrillation (AF) but the optimal target for blood pressure (BP) control in this patient population has not been clearly defined.

Methods

The Cardiovascular Risk reduction in patients with Atrial Fibrillation Trial (CRAFT) is an investigator-initiated and conducted, international, multicenter, open-label, parallel-group, blinded outcome assessed, randomized controlled trial of intensive BP control in patients with AF. The aim is to determine whether intensive BP control (target home systolic blood pressure [SBP] <120 mmHg) is superior to standard BP control (home SBP <135 mmHg) on the hierarchical composite outcome of time to CV death, number of stroke events, time to the first stroke, number of myocardial infarction (MI) events, time to the first MI, number of heart failure hospitalization (HFH) events, and time to the first HFH. A sample size of 1,675 patients is estimated to provide 80% power to detect a win-ratio of 1.50 for intensive versus standard BP control on the primary composite outcome. Study visits are conducted at 1, 2, 3, and 6 months postrandomization, and every 6 months thereafter during the study.

Conclusions

This clinical trial aims to provide reliable evidence of the effects of intensive BP control in patients with AF.

Trial registration

The trial is registered at ClinicalTrials.gov (NCT04347330)

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降低心房颤动患者心血管风险的强化血压控制随机对照试验方案：CRAFT 试验的原理与设计。

背景：合并高血压是心房颤动（房颤）患者不良心血管（CV）结局的有力预测因素，但该患者群体的最佳血压（BP）控制目标尚未明确：心房颤动患者降低心血管风险试验（CRAFT）是一项由研究者发起并开展的国际多中心、开放标签、平行分组、盲法结果评估、随机对照试验，旨在对心房颤动患者进行强化血压控制。目的是确定强化血压控制（目标家庭收缩压[SBP] 结论）是否对心房颤动患者有效：这项临床试验旨在为房颤患者强化血压控制的效果提供可靠的证据。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

American heart journal 医学-心血管系统

CiteScore

8.20

自引率

2.10%

发文量

214

审稿时长

38 days

期刊介绍： The American Heart Journal will consider for publication suitable articles on topics pertaining to the broad discipline of cardiovascular disease. Our goal is to provide the reader primary investigation, scholarly review, and opinion concerning the practice of cardiovascular medicine. We especially encourage submission of 3 types of reports that are not frequently seen in cardiovascular journals: negative clinical studies, reports on study designs, and studies involving the organization of medical care. The Journal does not accept individual case reports or original articles involving bench laboratory or animal research.