Division of Nephrology, The Ottawa Hospital and Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
Clinical Epidemiology Program, The Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Trials. 2022 Feb 14;23(1):147. doi: 10.1186/s13063-022-06071-9.
High blood pressure is the leading cause of cardiovascular disease worldwide. The prevalence of high blood pressure is steadily rising as the population grows amongst older adults with the ageing population. Therapeutical treatments are widely available to decrease blood pressures, in addition to many lifestyle options, such as dietary changes and exercise. There is a marked preference amongst patients, as reiterated by Hypertension Canada, for more research into non-therapeutic methods for controlling blood pressure or to reduce the burden of taking many pills to control high blood pressure. Indeed, effective options do exist, especially with diet, specifically decreasing sodium and increasing potassium intake. Current public health outreach primarily focusses on sodium intake, even though potassium intake remains low in the Western world. Excellent data exist in published research that increasing potassium intake, either via dietary modification or supplements, reduces blood pressure and reduces risk of cardiovascular outcomes such as stroke. However, the advice most often provided by medical professionals is to 'eat more fruits and vegetables' which has little impact on patient outcomes.
We propose to do a clinical trial in two stages with an adaptive trial design. In the first stage, participants with high blood pressure and proven low potassium intake (measured on the basis of a 24-h urine collection) will get individually tailored dietary advice, reinforced by weekly supportive phone/email support. At 4 weeks, if there has not been a measured increase in potassium intake, participants will be prescribed an additional potassium supplement. Testing will be conducted again at 8 weeks, to confirm the efficacy of the potassium supplement. Final measurements will be planned at 52 weeks to observe and measure the persistence of the effect of diet or additional supplement. Concurrent measurements of sodium intake, blood pressure, participant satisfaction, and safety measures will also be done.
The results of the study will help determine the most effective method of increasing potassium intake, thus reducing blood pressure and need for blood pressure-lowering medicines, and at the same time potentially increasing participant satisfaction. The current guidelines recommend changes in diet, not a potassium supplement, to increase potassium intake; hence, the two-stage design will only add supplements if the most rigorous dietary advice does not work.
This study has been registered on ClinicalTrials.gov NCT03809884 . Registered on January 18, 2019.
高血压是全球心血管疾病的主要病因。随着老年人口的增长，高血压的患病率稳步上升。除了许多生活方式选择，如饮食改变和锻炼外，还有广泛的治疗方法可降低血压。正如加拿大高血压协会所强调的那样，患者非常希望对控制血压的非治疗方法或减少服用许多药物来控制高血压的负担进行更多研究。事实上，确实存在有效的选择，特别是在饮食方面，特别是减少钠的摄入和增加钾的摄入。目前的公共卫生宣传主要集中在钠的摄入量上，尽管钾的摄入量在西方世界仍然很低。发表的研究中有很好的数据表明，通过饮食改变或补充剂增加钾的摄入量可以降低血压并降低心血管结果（如中风）的风险。然而，医疗专业人员提供的建议通常是“多吃水果和蔬菜”，但对患者的结果影响不大。
我们建议进行一项两阶段的临床试验，并采用适应性试验设计。在第一阶段，将对高血压和已证实的低钾摄入（根据 24 小时尿液收集测量）的参与者进行个体化饮食建议，并通过每周的支持电话/电子邮件提供支持。如果在 4 周内没有测量到钾摄入量的增加，参与者将被开处额外的钾补充剂。在 8 周时再次进行测试，以确认钾补充剂的疗效。最终测量计划在 52 周进行，以观察和测量饮食或额外补充剂的效果的持久性。同时还将进行钠摄入量、血压、参与者满意度和安全措施的并发测量。
研究结果将有助于确定增加钾摄入量的最有效方法，从而降低血压和降低降压药物的需求，同时可能提高参与者的满意度。目前的指南建议改变饮食，而不是钾补充剂，以增加钾的摄入量；因此，只有在最严格的饮食建议不起作用的情况下，两阶段设计才会添加补充剂。
这项研究已在 ClinicalTrials.gov 上注册，编号为 NCT03809884。于 2019 年 1 月 18 日注册。
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