TY - JOUR
T1 - Urinary proteomics combined with home blood pressure telemonitoring for health care reform trial
T2 - rational and protocol
AU - UPRIGHT-HTM Investigators
AU - Thijs, Lutgarde
AU - Asayama, Kei
AU - Maestre, Gladys E
AU - Hansen, Tine W
AU - Buyse, Luk
AU - Wei, Dong-Mei
AU - Melgarejo, Jesus D
AU - Brguljan-Hitij, Jana
AU - Cheng, Hao-Min
AU - de Souza, Fabio
AU - Gilis-Malinowska, Natasza
AU - Kawecka-Jaszcz, Kalina
AU - Mels, Carina
AU - Mokwatsi, Gontse
AU - Muxfeldt, Elisabeth S
AU - Narkiewicz, Krzysztof
AU - Odili, Augustine N
AU - Rajzer, Marek
AU - Schutte, Aletta E
AU - Stolarz-Skrzypek, Katarzyna
AU - Tsai, Yi-Wen
AU - Vanassche, Thomas
AU - Vanholder, Raymond
AU - Zhang, Zhen-Yu
AU - Verhamme, Peter
AU - Kruger, Ruan
AU - Mischak, Harald
AU - Staessen, Jan A
PY - 2021/10
Y1 - 2021/10
N2 - BACKGROUND: 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.METHODS: 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.EXPECTED OUTCOMES: 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.
AB - BACKGROUND: 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.METHODS: 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.EXPECTED OUTCOMES: 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.
KW - Aged
KW - Blood Pressure
KW - Health Care Reform
KW - Humans
KW - Hypertension
KW - Middle Aged
KW - Proteomics
KW - Randomized Controlled Trials as Topic
KW - Renal Insufficiency, Chronic
UR - http://www.scopus.com/inward/record.url?scp=85116034025&partnerID=8YFLogxK
U2 - 10.1080/08037051.2021.1952061
DO - 10.1080/08037051.2021.1952061
M3 - Article
C2 - 34461803
VL - 30
SP - 269
EP - 281
JO - Blood Pressure
JF - Blood Pressure
SN - 0803-7051
IS - 5
ER -