Rationale, design, and baseline characteristics of the Salt Substitute and Stroke Study (SSaSS) —A large-scale cluster randomized controlled trial

Publication date: June 2017 Source:American Heart Journal, Volume 188 Author(s): Bruce Neal, Maoyi Tian, Nicole Li, Paul Elliott, Lijing L. Yan, Darwin R. Labarthe, Liping Huang, Xuejun Yin, Zhixin Hao, Sandrine Stepien, Jingpu Shi, Xiangxian Feng, Jianxin Zhang, Yuhong Zhang, Ruijuan Zhang, Yangfeng Wu Lowering sodium intake with a reduced-sodium, added potassium salt substitute has been proved to lower blood pressure levels. Whether the same strategy will also reduce the risks of vascular outcomes is uncertain and controversial. The SSaSS has been designed to test whether sodium reduction achieved with a salt substitute can reduce the risk of vascular disease. The study is a large-scale, open, cluster-randomized controlled trial done in 600 villages across 5 provinces in China. Participants have either a history of stroke or an elevated risk of stroke based on age and blood pressure level at entry. Villages were randomized in a 1:1 ratio to intervention or continued usual care. Salt substitute is provided free of charge to participants in villages assigned to the intervention group. Follow-up is scheduled every 6months for 5years, and all potential endpoints are reviewed by a masked adjudication committee. The primary end point is fatal and nonfatal stroke, and the 2 secondary endpoints are total major cardiovascular events and total mortality. The study has been designed to provide 90% statistical power (with 2-sided α = .05) to detect a 13% or greater r...
Source: American Heart Journal - Category: Cardiology Source Type: research