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 - 10/11/24

Doi : 10.1016/j.ahj.2024.08.008

Chao Jiang, MD ^a,^b,^c,^{^{#
Chao Jiang and Zhiyan Wang contributed equally to this work.}}, Zhiyan Wang, MD ^a,^b,^{^{#
Chao Jiang and Zhiyan Wang contributed equally to this work.}}, Xin Du, MD, PhD ^a,^b,^c,^⁎ , Yufeng Wang, MD ^a,^b, Mingyang Gao, MD ^a,^b, Zhaoxu Jia, MD ^a,^b, Zhongyi Chai, MD ^d, Zhiyun Yang, MD ^e, Chi Wang, PhD ^c, Liu He, PhD ^a,^b, Rong Hu, MD ^a,^b, Qiang Lv, MD ^a,^b, Jiahui Wu, MD ^a,^b, Xu Li, MD ^a,^b, Changqi Jia, MD ^a,^b, Rong Han, ME ^c, Hisatomi Arima, MD, PhD ^f, Xia Wang, PhD ^g, Bruce Neal, MD, PhD ^g,^h, Anthony Rodgers, MD, PhD ^g, Graham S. Hillis, MD, PhD ⁱ, Anushka Patel, MD, PhD ^g, Qiang Li, M.Biostat ^g, Jianzeng Dong, MD ^a,^b,^c, Craig S. Anderson, MD, PhD ^c,^g,^j,^k , Changsheng Ma, MD ^a,^b,^⁎
^a Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, Beijing, China
^b National Clinical Research Center for Cardiovascular Diseases, Beijing, China
^c Heart Health Research Center, Beijing, China
^d Department of Cardiology, The First Affiliated Hospital of Zhengzhou University, Henan Province, China
^e Department of Cardiology, Peking University Third Hospital, Beijing, China
^f Department of Preventive Medicine and Public Health, Faculty of Medicine, Fukuoka University, Fukuoka, Japan
^g The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, Australia
^h School of Public Health, Imperial College London, London, UK
ⁱ Department of Cardiology, Royal Perth Hospital and Medical School, University of Western Australia, Perth, Western Australia, Australia
^j Department of Neurology, Royal Prince Alfred Hospital, University of Sydney, Sydney, Australia
^k Institute for Science and Techology for Brain-inspired Intelligence, Fudan University, Shanghai, China

^⁎Reprint requests: Changsheng Ma, MD, Xin Du, MD, PhD, Department of Cardiology, Beijing Anzhen Hospital, Capital Medical University, No. 2, Anzhen Road, Chao Yang District, Beijing, China 100029.Department of CardiologyBeijing Anzhen Hospital, Capital Medical UniversityNo. 2, Anzhen RoadChao Yang DistrictBeijing100029.China

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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Vol 278

P. 33-40 - décembre 2024 Retour au numéro

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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 - 10/11/24

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Background

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Trial registration

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