Dataset Information

Urinary proteomics combined with home blood pressure telemonitoring for health care reform trial: rational and protocol.

ABSTRACT:

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.

SUBMITTER: Thijs L

PROVIDER: S-EPMC9412130 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature

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Publications

Urinary proteomics combined with home blood pressure telemonitoring for health care reform trial: rational and protocol.

Thijs Lutgarde L Asayama Kei K Maestre Gladys E GE Hansen Tine W TW Buyse Luk L Wei Dong-Mei DM Melgarejo Jesus D JD Brguljan-Hitij Jana J Cheng Hao-Min HM de Souza Fabio F Gilis-Malinowska Natasza N Kawecka-Jaszcz Kalina K Mels Carina C Mokwatsi Gontse G Muxfeldt Elisabeth S ES Narkiewicz Krzysztof K Odili Augustine N AN Rajzer Marek M Schutte Aletta E AE Stolarz-Skrzypek Katarzyna K Tsai Yi-Wen YW Vanassche Thomas T Vanholder Raymond R Zhang Zhen-Yu ZY Verhamme Peter P Kruger Ruan R Mischak Harald H Staessen Jan A JA

Blood pressure 20210830 5

<h4>Background</h4>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.<h4>Methods</h4>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, ...[more]

PMID: 34461803

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Project description:BackgroundHypertension is the most important modifiable stroke risk factor, but blood pressure (BP) remains poorly controlled after stroke, especially among Black and Hispanic patients. We tested the feasibility of TASC (Telehealth After Stroke Care), a post-acute stroke care model integrating nurse-supported home BP telemonitoring, tailored infographics, and multidisciplinary team video visits.MethodsAcute stroke patients with hypertension were randomized at discharge to usual care or usual care with TASC. Usual care patients received video visits with primary care and stroke. TASC included a tablet and monitor to wirelessly transmit BP data to the electronic health record, with telenursing support, tailored infographics to explain BP readings, and pharmacist visits. Outcomes assessment was blinded. Feasibility outcomes included recruitment, randomization, adherence, and retention. Systolic BP from baseline to 3 months after discharge was evaluated using generalized linear modeling.ResultsFifty patients (64±14 years; 36% women' 44% Hispanic, 32% Black, 54% ≤high school education, 30% private insurance), and 75% of all eligible were enrolled over 6.3 months. Baseline systolic BP was similar in both (TASC n=25, 140±19 mm Hg; usual care n=25, 142±19 mm Hg). At 3 months, adherence to video visits (91% versus 75%, P=0.14) and retention (84% versus 64%, P=0.11) were higher with TASC. Home systolic BP declined by 16±19 mm Hg from baseline in TASC and increased by 3±24 mm Hg in usual care (P=0.01). Among Black patients, systolic BP control (<130 mm Hg) improved from 40% to 100% with TASC versus 14% to 29%, and among Hispanic patients, from 23% to 62% with TASC, versus 33% to 17% in usual care.ConclusionsEnhancing post-acute stroke care with home BP telemonitoring is feasible to improve hypertension in an underserved setting and should be tested in a definitive randomized clinical trial.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT04640519.

Dataset Information

Urinary proteomics combined with home blood pressure telemonitoring for health care reform trial: rational and protocol.

Background

Methods

Expected outcomes

Publications

Urinary proteomics combined with home blood pressure telemonitoring for health care reform trial: rational and protocol.

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