Background: Hypertension (HT) and type-2 diabetes (T2DM) 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.

Method: UPRIGHT-HTM (Urinary Proteomics Combined with Home Blood Pressure Telemonitoring for Health Care Reform [NCT04299529]) is an investigator-initiated 5-year clinical trial, which will randomize patients to be recruited in Europe, sub-Saharan Africa and South America (Blood Press 2021:269). 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 group), but only at trial closure in the other 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 HT, T2DM 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.

Results: As of 6 October 2022, 207 had been screened and 55/55 had been randomized to intervention/control at 20 centers. Baseline characteristics were similar, including sex (49.1% vs 40% men), ethnic distribution, age (61.8 vs 61.6 years), the prevalence of hypertension (98.2% vs 92.7%), T2DM (30.6% vs 37.3%), metabolic syndrome (3.8% vs 8.2%), eGFR (75.3 vs 78.9 mL/min/1.73m2), and the use of antihypertensive, lipid-lowering and antidiabetic drugs. Around 50,000 home blood pressure readings were registered in the total screened population. The systolic/diastolic blood pressure was similar in the randomized patients (averaged 126.4/9.1 vs 129.2/10.1 mmHg (P=0.13).

Conclusion: The UPRIGHT-HTM trial will provide novel information on the combination of blood pressure telemonitoring combined with UPP vs blood pressure alone in risk stratification.