UPRIGHT-HTM will compare risk stratification, treatment efficiency and health economic outcomes of a diagnostic approach based on home blood pressure telemonitoring combined with urinary proteomic profiling with home blood pressure telemonitoring alone
Patients must have at least three additional guideline-defined risk factors, preferably including hypertension, type 2 diabetes mellitus (T2DM), or both;
Patients should be willing patients to engage for the duration of the study in home blood pressure telemonitoring (1 reading per day);
Patients must have an email address and internet access via smartphone, tablet, or laptop or desktop computer;
Patients should comply with the study protocol during the run-in phase.
Type 1 diabetes mellitus;
Absence of a practicable echocardiographic window;
Previous or concurrent severe cardiovascular or non-cardiovascular disease;
Cancer within 5 years of enrolment;
Parallel
In-vitro urinary diagnostic test
Diagnostic testUrinary proteomic profiling (UPP) using established multidimensional urinary markers for progression to CKD (CKD273), left ventricular dysfunction (HF1 and HF2) and coronary heart disease (CAD238 and ACSP75) - in-vitro test certified in Germany and by extension in the EU (DE/CA09/0829/IVD/001, DE/CA09/0829/IVD/005).
Primary composite endpoint
The primary endpoint is a composite of intermediary and "hard" cardiovascular-renal endpoints. The "intermediate endpoints" are diabetic nephropathy, progression to a higher CKD stage, doubling of serum creatinine, an eGFR decrease by 30% or more or eGFR declining below 45 ml/min/1.73 m2, new-onset hypertensive or diabetic retinopathy, electrocardiographic or echocardiographic left ventricle hypertrophy, and diastolic left ventricular dysfunction. The "hard" composite cardiovascular endpoint includes cardiovascular mortality, and nonfatal myocardial infarction, nonfatal hospitalised heart failure, and nonfatal stroke, not including transient ischemic attack. The "hard" renal outcomes include macroalbuminuria, the need for renal-replacement therapy, and death to renal causes.
Change in serum creatinine (mg/dl)
The concentration of creatinine in serum, expressed in mg/dl, will be measured, using Jaffe's method with modifications () in certified laboratories applying isotope-dilution mass spectrometry for calibration (Clin Chem 2006; 52: 5-18).
Change in eGFR (ml/min/1.73m2)
eGFR will be derived from the serum creatinine concentration by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Ann Intern Med 2009; 150: 604-612) and expressed in ml/min/1.73 m2.
Progression of CKD
The National Kidney Foundation Kidney Disease Outcomes Quality Initiative guideline will be followed (Kidney Int Suppl 2013;3:1-150): eGFR ≥90, 60-89, 45-59, 30-44, 15-29 and \<15 mL/min/1.73 m2 for Stage 1, 2, 3A, 3B, 4 and 5, respectively
EQ-5D (scale ranging from 0 [worst possible] to 100 [best possible])
Quality of life will be assessed using the EQ-5D quality of life questionnaire (http://www.euroqol.org)
Health-economic analysis
For health-economic evaluation, the EQ-5D patient-administered questionnaire (https://www.euroqol.org) is of particular importance, as Quality Adjusted Life Years (QALYs) can be generated from this simple instrument
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KU Leuven
Lead sponsor
Alliance for the Promotion of Preventive Medicine
Collaborator
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