Research Unit Hypertension and Cardiovascular Epidemiology, KU Leuven Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.
Department of Hygiene and Public Health, Teikyo University School of Medicine, Tokyo, Japan.
Blood Press. 2021 Oct;30(5):269-281. doi: 10.1080/08037051.2021.1952061. Epub 2021 Aug 30.
Hypertension and diabetes cause chronic kidney disease (CKD) and diastolic left ventricular dysfunction (DVD) as forerunners of disability and death. Home blood pressure telemonitoring (HTM) and urinary peptidomic profiling (UPP) are technologies enabling prevention.
UPRIGHT-HTM (Urinary Proteomics Combined with Home Blood Pressure Telemonitoring for Health Care Reform [NCT04299529]) is an investigator-initiated 5-year clinical trial with patient-centred design, which will randomise 1148 patients to be recruited in Europe, sub-Saharan Africa and South America. During the whole study, HTM data will be collected and freely accessible for patients and caregivers. The UPP, measured at enrolment only, will be communicated early during follow-up to 50% of patients and their caregivers (intervention), but only at trial closure in 50% (control). The hypothesis is that early knowledge of the UPP risk profile will lead to more rigorous risk factor management and result in benefit. Eligible patients, aged 55-75 years old, are asymptomatic, but have ≥5 CKD- or DVD-related risk factors, preferably including hypertension, type-2 diabetes, or both. The primary endpoint is a composite of new-onset intermediate and hard cardiovascular and renal outcomes. Demonstrating that combining UPP with HTM is feasible in a multicultural context and defining the molecular signatures of early CKD and DVD are secondary endpoints.
The expected outcome is that application of UPP on top of HTM will be superior to HTM alone in the prevention of CKD and DVD and associated complications and that UPP allows shifting emphasis from treating to preventing disease, thereby empowering patients.
高血压和糖尿病导致慢性肾病（CKD）和舒张性左心室功能障碍（DVD），成为残疾和死亡的先兆。家庭血压远程监测（HTM）和尿肽组学分析（UPP）是实现预防的技术。
URIGHT-HTM（用于医疗保健改革的尿蛋白质组学联合家庭血压远程监测[NCT04299529]）是一项具有以患者为中心设计的为期 5 年的临床研究，将招募来自欧洲、撒哈拉以南非洲和南美洲的 1148 名患者进行随机分组。在整个研究过程中，将收集 HTM 数据并免费提供给患者和护理人员。仅在入组时测量的 UPP 将在随访早期传递给 50%的患者及其护理人员（干预组），但仅在 50%的患者（对照组）中在试验结束时传递。假设是，早期了解 UPP 的风险概况将导致更严格的危险因素管理，并带来益处。符合条件的患者年龄在 55-75 岁之间，无症状，但有≥5 个与 CKD 或 DVD 相关的危险因素，最好包括高血压、2 型糖尿病或两者兼有。主要终点是新发的中危和高危心血管及肾脏复合结局。证明在多元文化背景下，将 UPP 与 HTM 相结合是可行的，并确定早期 CKD 和 DVD 的分子特征是次要终点。
预期结果是，在预防 CKD 和 DVD 及其相关并发症方面，UPP 联合 HTM 的应用将优于单独 HTM，并且 UPP 允许从治疗疾病转向预防疾病，从而增强患者的能力。
