Urinary Proteomics Combined With Home Blood Pressure Telemonitoring for Health Care Reform

NCT ID: NCT04299529

Last Updated: 2020-03-06

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2026-07-31

Brief Summary

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

Detailed Description

Hypertension is by far the dominant reversible risk factor dwarfing most others in the pathogenesis of chronic kidney disease (CKD) and diastolic left ventricular dysfunction (DVD), two archetypes of chronic age-related diseases, which are rampant in ageing societies in epidemiological transition. Home blood pressure telemonitoring (HTM) is a recommended approach in the diagnosis and management of hypertension. Urinary peptidomic profiling (UPP) holds great promise in individualising prevention and treatment of CKD and DVD and associated complications, such as coronary heart disease. Making use of these modern technologies, UPRIGHT-HTM is an investigator-initiated randomised clinical trial with a patient-centred design, for the first time, comparing HTM combined UPP (experimental group) to HTM alone (control group) in risk profiling and as guide to starting or intensifying management of risk factors to prevent established disease. The trial will run in Europe, sub-Saharan Africa and South America. Eligible patients, aged 55-75 years old, are asymptomatic, but have three or more CKD- or DVD-related risk factors, preferably including hypertension, type 2 diabetes mellitus, or both, and do have internet skills. The primary endpoint consists of a composite of new-onset intermediate endpoints (microalbuminuria, progression of CKD, diabetic or hypertensive retinopathy, electrocardiographic or echocardiographic left ventricular hypertrophy or DVD and hard outcomes (cardiovascular mortality and non-fatal complications, including myocardial infarction, heart failure and stroke). Secondary objectives are demonstrating that combining HTM with UPP is feasible and cost-effective in a multicultural context, defining the molecular signatures of early CKD and DVD, and with help of stakeholders educating and empowering patients. Assuming an accrual time of 1 year, a median follow-up of 4 years, a 10% dropout rate, a 20% risk of the primary endpoint in the control group and 30% risk reduction in the experimental group, requires 1000 patients to be randomised in a 1:1 proportion with the two-sided alpha level and power set 0.05 and 0.80, respectively. The expected outcome is proving the superiority in terms of efficiency and cost-effectiveness of HTM combined with UPP vs HTM alone, which should lead to redesigning the clinical workflow, putting greater emphasis on preventing rather than curing established disease.

Conditions

Protein Deregulation; Blood Pressure; Health Care Utilization; Cost Effectiveness; Patient Empowerment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

HTM plus UPP

Urinary proteomic profiling administered on top of home blood pressure telemonitoring and guideline-endorsed non-pharmacological and pharmacological management of risk factors

Group Type: EXPERIMENTAL

In-vitro urinary diagnostic test

Intervention Type: DIAGNOSTIC_TEST

Urinary 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).

HTM alone

Home blood pressure telemonitoring administered on top of non-pharmacological and pharmacological management of risk factors

Group Type: OTHER

In-vitro urinary diagnostic test

Intervention Type: DIAGNOSTIC_TEST

Urinary 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).

Interventions

In-vitro urinary diagnostic test

Urinary 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).

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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;
• Suspected substance abuse;
• Psychiatric illness;
• Use of nephrotoxic drugs;
• Particpation in another clinical study.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alliance for the Promotion of Preventive Medicine

UNKNOWN

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Jan A. Staessen

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lutgarde Thijs, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Leuven

Locations

European Kidney Health Aliance

Brussels, , Belgium

Diabetes Liga

Ghent, , Belgium

Alliance for the Promotion of Preventive Medicine

Mechelen, , Belgium

Steno Diabetes Center Copenhagen

Gentofte Municipality, , Denmark

Mosaiques-Diagnoostics and Therapeutics AG

Hanover, , Germany

Biomedical Research Foundation of the Academy of Athens

Athens, , Greece

Department of Internal Medicine, Faculty of Clinical Sciences, College of Health Sciences, University of Abuja

Abuja, , Nigeria

Department of Hypertension, Medical University of Gdańsk

Gdansk, , Poland

First Department of Cardiology, Interventional Electrocardiology and Hypertension, Jagiellonian University Medical College

Krakow, , Poland

Department of Internal Medicine, Division of Hypertension, University Medical Centre Ljubljana

Ljubljana, , Slovenia

Hypertension in Africa Research Team, Medical Research Council Unit for Hypertension and Cardiovascular Disease, North-West University

Potchefstroom, , South Africa

Centro de Nefrología and Departamento de Fisiopatología, Hospital de Clínicas, Universidad de la República

Montevideo, , Uruguay

Countries

Belgium; Denmark; Germany; Greece; Nigeria; Poland; Slovenia; South Africa; Uruguay

Central Contacts

Jan A Staessen, MD, PhD

Role: CONTACT

jan.staessen@med.kuleuven.be

+32 47 632 4928

Zen-Yu Zhang, MD, PhD

Role: CONTACT

zhenyu.zhang@med.kuleuven.be

+32 16 34 7104

Facility Contacts

Tine W Hansen, MD, PhD

Role: primary

tine.willum.hansen@regionh.dk

+45 39 68 08 00

Augustine N Odili, MD, PhD

Role: primary

odilimercy@yahoo.com

+234 803 395 4983

Krzysztof Narkiewicz, MD, PhD

Role: primary

krzysztof.narkiewicz@gumed.edu.pl

Mariana Smoluchowskiego

Role: backup

+58 584 44 40

Marek Raizer, MD, PhD

Role: primary

marek.raizer@uj.edu.pl

+4812 4002150

Jana Brguljan Hitij, MD, PhD

Role: primary

jana.brguljan-hitij@guest.arnes.si

+386 1 522 50 50

Alta Schutte, MD, PhD

Role: primary

alta.schutte@nwu.ac.za

+27 18 299 1111

José Boggia, MD, PhD

Role: primary

ppboggia@gmail.com

+598 2480 98 50

References

Chori BS, An DW, Martens DS, Yu YL, Gilis-Malinowska N, Abubakar SM, Ibrahim EA, Ajanya O, Abiodun OO, Anya T, Tobechukwu I, Isiguzo G, Cheng HM, Chen CH, Liao CT, Mokwatsi G, Stolarz-Skrzypek K, Wojciechowska W, Narkiewicz K, Rajzer M, Brguljan-Hitij J, Nawrot TS, Asayama K, Reyskens P, Mischak H, Odili AN, Staessen JA; UPRIGHT-HTM Investigators. Urinary proteomics combined with home blood pressure telemonitoring for health care reform trial-First progress report. J Clin Hypertens (Greenwich). 2023 Jun;25(6):521-533. doi: 10.1111/jch.14664. Epub 2023 May 6.

Reference Type: DERIVED

PMID: 37147930 (View on PubMed)

Other Identifiers

UPRIGHT-HTM, version 4.0

Identifier Type: -

Identifier Source: org_study_id