Urinary proteomics combined with home blood pressure telemonitoring for health care reform trial-First progress report

Abstract

High blood pressure (BP) and type-2 diabetes (T2DM) are forerunners of chronic kidney disease and left ventricular dysfunction. Home BP telemonitoring (HTM) and urinary peptidomic profiling (UPP) are technologies enabling risk stratification and personalized prevention. UPRIGHT-HTM (NCT04299529) is an investigator-initiated, multicenter, open-label, randomized trial with blinded endpoint evaluation designed to assess the efficacy of HTM plus UPP (experimental group) over HTM alone (control group) in guiding treatment in asymptomatic patients, aged 55-75 years, with ≥5 cardiovascular risk factors. From screening onwards, HTM data can be freely accessed by all patients and their caregivers; UPP results are communicated early during follow-up to patients and caregivers in the intervention group, but at trial closure in the control group. From May 2021 until January 2023, 235 patients were screened, of whom 53 were still progressing through the run-in period and 144 were randomized. Both groups had similar characteristics, including average age (62.0 years) and the proportions of African Blacks (81.9%), White Europeans (16.7%), women 56.2%, home (31.2%), and office (50.0%) hypertension, T2DM (36.4%), micro-albuminuria (29.4%), and ECG (9.7%) and echocardiographic (11.5%) left ventricular hypertrophy. Home and office BP were 128.8/79.2 mm Hg and 137.1/82.7 mm Hg, respectively, resulting in a prevalence of white-coat, masked and sustained hypertension of 40.3%, 11.1%, and 25.7%. HTM persisted after randomization (48 681 readings up to 15 January 2023). In conclusion, results predominantly from low-resource sub-Saharan centers proved the feasibility of this multi-ethnic trial. The COVID-19 pandemic caused delays and differential recruitment rates across centers.

Keywords: chronic kidney disease; home blood pressure telemonitoring; hypertension; left ventricular function; risk factors; type-2 diabetes mellitus.

FIGURE 1

UPRIGHT‐HTM design. eCRF, electronic report forms completed by investigators; EP, absence (−) / incidence (+) of the components of the primary endpoint during the run‐in/follow‐up periods, respectively; IC, written informed consent; pINF, patients received the UPRIGHT‐HTM information sheet and were familiarized with operating the blood pressure monitoring devices; pQ, patient‐administered questionnaires, R, randomization after stratification for center and sex; S, initial screening; UPP, urinary proteomic profiling (mandatory prior to randomization—optional at the end of follow‐up). Reproduced from open‐access reference 5.

FIGURE 2

Flow Chart. HTM refers to home blood pressure telemonitoring.

FIGURE 3

Distributions of the Office (A,C) and Home (B,D) systolic and diastolic blood pressure. The solid and dotted lines represent the normal and kernel density distributions. p‐values are for departure of the actually observed distribution from normality according to the Shapiro‐Wilk statistic. M indicates the arithmetic mean. Skewness (S) and kurtosis (K) were computed as the third and fourth moments about the mean divided by the cube of the standard deviation. The home blood pressure was the average of all readings from screening to randomization.