Department of Internal Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.
Department of Hospital Pharmacy, Erasmus MC, Erasmus University Medical Centre, Rotterdam, The Netherlands.
BMC Cardiovasc Disord. 2023 Feb 14;23(1):87. doi: 10.1186/s12872-023-03114-0.
Adherence to antihypertensive drugs (AHDs) is important for adequate blood pressure control. Not taking these drugs as prescribed is one of the main underlying causes for resistant hypertension (RH), which in turn leads to an increased risk of cardiovascular events, stroke and kidney damage. Therefore, correct identification of patients that are non-adherent to AHDs is crucial to improve clinical outcome. For this goal, therapeutic drug monitoring is the most reliable method. The primary objective of this trial is to investigate whether monitoring of drug concentrations with a dried blood spot (DBS) sampling method combined with personalised feedback leads to a decrease in prevalence of RH after 12 months due to an increase in adherence. Secondary objectives include the difference over time in the number of required AHDs as well as the defined daily dose (DDD). Lastly, the cost-utility of SoC versus the intervention in RH is determined.
This is a multi-centre single-blinded randomised controlled trial (RHYME-RCT). First, at an eligibility visit, DBS sampling, to monitor drug concentrations in blood, and a 24-h ambulatory blood pressure measurement (24-h ABPM) are performed simultaneously. Patients with a daytime systolic blood pressure (SBP) > 135 and/or diastolic blood pressure (DBP) > 85 mmHg are randomised to SoC or intervention + SoC. The intervention is performed by the treating physician and includes information on drug concentrations and a comprehensive personalised feedback conversation with the use of a communication tool. The follow-up period is one year with visits at 3, 6 and 12 months randomisation and includes 24-h ABPM and DBS sampling.
This will be the first trial that focusses specifically on patients with RH without taking into account suspicion of non-adherence and it combines monitoring of AHD concentrations to identify non-adherence to AHDs with a comprehensive feedback to improve non-adherence. Furthermore, if this trial shows positive outcomes for the intervention it can be directly implemented in clinical practice, which would be a great improvement in the treatment of RH.
RHYME-RCT is registered in the Dutch Trial Register on 27/12/2017 (NTR6914) and can be found in the International Clinical Trials Registry Platform.
抗高血压药物（AHD）的依从性对于充分控制血压很重要。未按规定服用这些药物是难治性高血压（RH）的主要潜在原因之一，这反过来又会增加心血管事件、中风和肾脏损害的风险。因此，正确识别不依从 AHD 的患者对于改善临床结局至关重要。为此，治疗药物监测是最可靠的方法。本试验的主要目的是研究通过干血斑（DBS）采样方法结合个性化反馈监测药物浓度是否会导致 12 个月后 RH 的患病率因依从性增加而降低。次要目标包括随时间推移 AHD 数量的差异以及定义日剂量（DDD）。最后，确定 SOC 与 RH 干预的成本效益。
这是一项多中心、单盲、随机对照试验（RHYME-RCT）。首先，在入选时，同时进行 DBS 采样以监测血液中的药物浓度和 24 小时动态血压测量（24-h ABPM）。白天收缩压（SBP）>135mmHg 和/或舒张压（DBP）>85mmHg 的患者随机分为 SOC 或干预+SOC。干预由主治医生进行，包括药物浓度信息和使用沟通工具进行全面的个性化反馈对话。随访期为 1 年，在随机分组后 3、6 和 12 个月进行随访，包括 24-h ABPM 和 DBS 采样。
这将是第一个专门针对 RH 患者的试验，不考虑对不依从的怀疑，并将 AHD 浓度监测与识别不依从 AHD 的全面反馈相结合，以改善不依从。此外，如果该试验显示干预有积极结果，它可以直接在临床实践中实施，这将是 RH 治疗的重大改进。
RHYME-RCT 于 2017 年 12 月 27 日在荷兰试验注册处注册（NTR6914），并可在国际临床试验注册平台上找到。
