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
{"title":"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。","authors":"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","doi":"10.1016/j.ahj.2024.08.008","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Conclusions</h3><p>This clinical trial aims to provide reliable evidence of the effects of intensive BP control in patients with AF.</p></div><div><h3>Trial registration</h3><p>The trial is registered at ClinicalTrials.gov (NCT04347330)</p></div>","PeriodicalId":7868,"journal":{"name":"American heart journal","volume":"278 ","pages":"Pages 33-40"},"PeriodicalIF":3.7000,"publicationDate":"2024-09-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"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\",\"authors\":\"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\",\"doi\":\"10.1016/j.ahj.2024.08.008\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Conclusions</h3><p>This clinical trial aims to provide reliable evidence of the effects of intensive BP control in patients with AF.</p></div><div><h3>Trial registration</h3><p>The trial is registered at ClinicalTrials.gov (NCT04347330)</p></div>\",\"PeriodicalId\":7868,\"journal\":{\"name\":\"American heart journal\",\"volume\":\"278 \",\"pages\":\"Pages 33-40\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2024-09-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"American heart journal\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S0002870324002035\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"American heart journal","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0002870324002035","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
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
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)
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.
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