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Published in: Trials 1/2020

01-12-2020 | Blood Pressure Measurement | Study protocol

Achieving blood pressure control targets in hypertensive patients of rural China – a pilot randomized trial

Authors: Xiao Huang, Lishun Liu, Yun Song, Lan Gao, Min Zhao, Huihui Bao, Xianhui Qin, Yanqing Wu, Qinghua Wu, Chonglei Bi, Aiping Yue, Chongqian Fang, Hai Ma, Yimin Cui, Genfu Tang, Ping Li, Yan Zhang, Jianping Li, Binyan Wang, Xiping Xu, Hong Wang, Gianfranco Parati, J. David Spence, Xiaobin Wang, Yong Huo, Guangliang Chen, Xiaoshu Cheng, for the investigators of intensive BP control in China

Published in: Trials | Issue 1/2020

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Abstract

Background

This study aimed to test the feasibility and titration methods used to achieve specific blood pressure (BP) control targets in hypertensive patients of rural China.

Methods

A randomized, controlled, open-label trial was conducted in Rongcheng, China. We enrolled 105 hypertensive participants aged over 60 years, and who had no history of stroke or cardiovascular disease. The patients were randomly assigned to one of three systolic-BP target groups: standard: 140 to < 150 mmHg; moderately intensive: 130 to < 140 mmHg; and intensive: < 130 mmHg. The patients were followed for 6 months.

Discussion

The optimal target for systolic blood pressure (SBP) lowering is still uncertain worldwide and such information is critically needed, especially in China. However, in China the rates of awareness, treatment and control are only 46.9%, 40.7%, and 15.3%, respectively. It is challenging to achieve BP control in the real world and it is very important to develop population-specific BP-control protocols that fully consider the population’s characteristics, such as age, sex, socio-economic status, compliance with medication, education level, and lifestyle. This randomized trial showed the feasibility and safety of the titration protocol to achieve desirable SBP targets (< 150, < 140, and < 130 mmHg) in a sample of rural, Chinese hypertensive patients. The three BP target groups had similar baseline characteristics. After 6 months of treatment, the mean SBP measured at an office visit was 137.2 mmHg, 131.1 mmHg, and 124.2 mmHg, respectively, in the three groups. Home BP and central aortic BP measurements were also obtained. At 6 months, home BP measurements (2 h after drug administration) showed a mean SBP of 130.9 mmHg in the standard group, 124.9 mmHg in the moderately intensive group, and 119.7 mmHg in the intensive group. No serious adverse events were recorded over the 6-month study period. Rates of adverse events, including dry cough, palpitations, and arthralgia, were low and showed no significant differences between the three groups. This trial provided real-world experience and laid the foundation for a future, large-scale, BP target study.

Trial registration

Feasibility Study of the Intensive Systolic Blood Pressure Control; ClinicalTrials.gov, ID: NCT02817503. Registered retrospectively on 29 June 2016.
Appendix
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Metadata
Title
Achieving blood pressure control targets in hypertensive patients of rural China – a pilot randomized trial
Authors
Xiao Huang
Lishun Liu
Yun Song
Lan Gao
Min Zhao
Huihui Bao
Xianhui Qin
Yanqing Wu
Qinghua Wu
Chonglei Bi
Aiping Yue
Chongqian Fang
Hai Ma
Yimin Cui
Genfu Tang
Ping Li
Yan Zhang
Jianping Li
Binyan Wang
Xiping Xu
Hong Wang
Gianfranco Parati
J. David Spence
Xiaobin Wang
Yong Huo
Guangliang Chen
Xiaoshu Cheng
for the investigators of intensive BP control in China
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04368-1

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