Protein DeregulationUPRIGHT-HTMNCT04299529
Urinary Proteomics Combined With Home Blood Pressure Telemonitoring for Health Care Reform
A study testing In-vitro urinary diagnostic test in people with Protein Deregulation and Blood Pressure, run by KU Leuven at 12 sites in 9 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Protein Deregulation, Blood Pressure, Health Care Utilization
- What is being tested?
- In-vitro urinary diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 12 sitesin 9 countries
- Study dates
- 1 Apr 2020to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 9 countries.
12 sites in 9 countries
Belgium3 sites
European Kidney Health Aliance
Brussels, 1000
Diabetes Liga
Ghent, 9000
Alliance for the Promotion of Preventive Medicine
Mechelen, 2800
Poland2 sites
Department of Hypertension, Medical University of Gdańsk
Gdansk, 80-214
Krzysztof Narkiewicz, MD, PhD, krzysztof.narkiewicz@gumed.edu.pl
Mariana Smoluchowskiego, +58 584 44 40
First Department of Cardiology, Interventional Electrocardiology and Hypertension, Jagiellonian University Medical College
Krakow
Marek Raizer, MD, PhD, +4812 4002150, marek.raizer@uj.edu.pl
Katarzyna Stolarz-Skrzypek, MD, PhD
Denmark1 site
Steno Diabetes Center Copenhagen
Gentofte Municipality, 2820
Tine W Hansen, MD, PhD, +45 39 68 08 00, tine.willum.hansen@regionh.dk
Greece1 site
Biomedical Research Foundation of the Academy of Athens
Athens, 115 27
Nigeria1 site
Department of Internal Medicine, Faculty of Clinical Sciences, College of Health Sciences, University of Abuja
Abuja, NCT Airport Road
Augustine N Odili, MD, PhD, +234 803 395 4983, odilimercy@yahoo.com
Slovenia1 site
Department of Internal Medicine, Division of Hypertension, University Medical Centre Ljubljana
Ljubljana, 1000
Jana Brguljan Hitij, MD, PhD, +386 1 522 50 50, jana.brguljan-hitij@guest.arnes.si
South Africa1 site
Hypertension in Africa Research Team, Medical Research Council Unit for Hypertension and Cardiovascular Disease, North-West University
Potchefstroom, 2520
Alta Schutte, MD, PhD, +27 18 299 1111, alta.schutte@nwu.ac.za
Carina Mels, MD, PhD
Uruguay1 site
Centro de Nefrología and Departamento de Fisiopatología, Hospital de Clínicas, Universidad de la República
Montevideo, 11600
José Boggia, MD, PhD, +598 2480 98 50, ppboggia@gmail.com
About this study
Official title: Urinary Proteomics Combined With Home Blood Pressure Telemonitoring for Health Care Reform: a Randomised Controlled Trial
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
Read the 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
- Being tested
- In-vitro urinary diagnostic test
- Medical subject headings
- Patient Acceptance of Health Care, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-vitro urinary diagnostic testDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| HTM plus UPP | Experimental | Urinary proteomic profiling administered on top of home blood pressure telemonitoring and guideline-endorsed non-pharmacological and pharmacological management of risk factors Receives: Diagnostic Test: In-vitro urinary diagnostic test |
| HTM alone | Other | Home blood pressure telemonitoring administered on top of non-pharmacological and pharmacological management of risk factors Receives: Diagnostic Test: In-vitro urinary diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
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).
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
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.
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
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
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of diabetic nephropathy
Microalbuminuria of 30 microgram per gram creatinine or more in two of three morning urine samples collected on three consecutive days.
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of diabetic retinopathy
Non-proliferative diabetic retinopathy (NPDR): early NPDR, at least one microaneurysm ; moderate NDPR, characterized by multiple microaneurysms, dot-and-blot hemorrhages, venous beading, and/or cotton wool spots; severe NPDR, diffuse intraretinal hemorrhages and microaneurysms in four quadrants, venous beading in two or more quadrants, or severe intraretinal microvascular abnormalities
Proliferative diabetic retinopathy (PDR): fibrovascular proliferation extending beyond the internal limiting membrane; vitreous hemorrhage; retinal detachment, macular edema
(https:// https://webeye.ophth.uiowa.edu/eyeforum/tutorials/Diabetic-Retinopathy-Med-Students/Classification.htm)
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of hypertensive retinopathy
Grade 1: mild narrowing and tortuosity of the retinal arterioles; Grade 2: definite focal retinal arteriolar narrowing and arteriovenous nipping; Grade 3: retinal hemorrhages and cotton wool spots; Grade 4: papilledema
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of electrocardiographic LV hypertrophy
The Sokolow-Lyon index is the sum of the S-wave in V1 and the R wave in V5 or V6, whichever is greater; the threshold value is 3.5 mV (PMID 31352838, 19015402, 28789616); in regularly calibrated ECGs, 1 mV is 10 mm along the vertical axis;
The Cornell product is the sum of RaVL and RV5 with 6 mV added for women, multiplied by the QRS duration in milliseconds; the cut-off value is 2440 mV × ms (PMID 31352838, 19015402, 28789616);
Increased R-wave in aVL: the threshold values is 1.1 mV;
ST segment down sloping in V4-V6 with T-top inversion.
Based on these criteria the investigators will classify patients as having or not having electrocariographic LV hypertrophy
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of echocardiographic LV hypertrophy
Guidelines should be applied for acquisition and off-line analysis of the echocardiographic imaging studies (PMID 15452478, 19187853, 27037982); LV mass will be calculated using a formula validated by necropsy (PMID 2936235, 15452478); LVM = 0.8 × (1.04 × (EDD + IVS + LPW)3 - EDD)3) + 0.6; expressed in gram; LV mass will be indexed to body surface; the threshold values are ≥95/≥115 g/m2 in women/men.
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of diastolic LV dysfunction
Diastolic LV dysfunction will be defined as an abnormally low age-specific transmitral E/A ratio, indicative of impaired relaxation, or a mildly-to-moderately elevated left ventricular filling pressure (E/e' >8.5) with normal or decreased age-specific E/A ratio. The ejection fraction should be over 50% (Circ Heart Fail 2009;2: 105-112).
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of CV mortality
ICD10 codes I00-I99
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of nonfatal myocardial infarction
ICD10 codes I21,I22
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of nonfatal heart failure
ICD10 code I50
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of nonfatal stroke
ICD10 codes I60-I63
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Incidence of CKD
ICD10 codes N17, N18
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Secondary outcomes (2)
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)
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years.
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
Measured: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Protein DeregulationStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance for the Promotion of Preventive Medicine
- Responsible party
- Principal investigator, Jan A. Staessen, KU Leuven
- Investigators
- Lutgarde Thijs, MSc, Principal investigator, University of Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299529
- Sponsor's protocol ID
- UPRIGHT-HTM, version 4.0
- Acronym
- UPRIGHT-HTM
- Status last verified
- Mar 2020
- First submitted
- 2 Mar 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A motivated request for data transfer for scientific purposes should be addressed to Prof Jan A. Staessen
Publications
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.
PubMed 37147930
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Proteomics Combined With Home Blood Pressure Telemonitoring for Health Care Reform: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04299529
- Acronym / sponsor ID
- UPRIGHT-HTM / UPRIGHT-HTM, version 4.0
- Conditions
- Protein Deregulation, Blood Pressure, Health Care Utilization, Cost Effectiveness, Patient Empowerment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Collaborators
- Alliance for the Promotion of Preventive Medicine
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 6 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group design
| Arm | Type | Receives |
|---|---|---|
| HTM plus UPP | Experimental | Diagnostic Test: In-vitro urinary diagnostic testUrinary proteomic profiling administered on top of home blood pressure telemonitoring and guideline-endorsed non-pharmacological and pharmacological management of risk factors |
| HTM alone | Other | Diagnostic Test: In-vitro urinary diagnostic testHome blood pressure telemonitoring administered on top of non-pharmacological and pharmacological management of risk factors |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-vitro urinary 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). | Diagnostic test | HTM alone, HTM plus UPP |
Primary outcome
Primary composite endpoint
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
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)
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
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)
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
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
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
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
Incidence of diabetic nephropathy
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Microalbuminuria of 30 microgram per gram creatinine or more in two of three morning urine samples collected on three consecutive days.
Incidence of diabetic retinopathy
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Non-proliferative diabetic retinopathy (NPDR): early NPDR, at least one microaneurysm ; moderate NDPR, characterized by multiple microaneurysms, dot-and-blot hemorrhages, venous beading, and/or cotton wool spots; severe NPDR, diffuse intraretinal hemorrhages and microaneurysms in four quadrants, venous beading in two or more quadrants, or severe intraretinal microvascular abnormalities Proliferative diabetic retinopathy (PDR): fibrovascular proliferation extending beyond the internal limiting membrane; vitreous hemorrhage; retinal detachment, macular edema (https:// https://webeye.ophth.uiowa.edu/eyeforum/tutorials/Diabetic-Retinopathy-Med-Students/Classification.htm)
Incidence of hypertensive retinopathy
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Grade 1: mild narrowing and tortuosity of the retinal arterioles; Grade 2: definite focal retinal arteriolar narrowing and arteriovenous nipping; Grade 3: retinal hemorrhages and cotton wool spots; Grade 4: papilledema
Incidence of electrocardiographic LV hypertrophy
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
The Sokolow-Lyon index is the sum of the S-wave in V1 and the R wave in V5 or V6, whichever is greater; the threshold value is 3.5 mV (PMID 31352838, 19015402, 28789616); in regularly calibrated ECGs, 1 mV is 10 mm along the vertical axis; The Cornell product is the sum of RaVL and RV5 with 6 mV added for women, multiplied by the QRS duration in milliseconds; the cut-off value is 2440 mV × ms (PMID 31352838, 19015402, 28789616); Increased R-wave in aVL: the threshold values is 1.1 mV; ST segment down sloping in V4-V6 with T-top inversion. Based on these criteria the investigators will classify patients as having or not having electrocariographic LV hypertrophy
Incidence of echocardiographic LV hypertrophy
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Guidelines should be applied for acquisition and off-line analysis of the echocardiographic imaging studies (PMID 15452478, 19187853, 27037982); LV mass will be calculated using a formula validated by necropsy (PMID 2936235, 15452478); LVM = 0.8 × (1.04 × (EDD + IVS + LPW)3 - EDD)3) + 0.6; expressed in gram; LV mass will be indexed to body surface; the threshold values are ≥95/≥115 g/m2 in women/men.
Incidence of diastolic LV dysfunction
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
Diastolic LV dysfunction will be defined as an abnormally low age-specific transmitral E/A ratio, indicative of impaired relaxation, or a mildly-to-moderately elevated left ventricular filling pressure (E/e' >8.5) with normal or decreased age-specific E/A ratio. The ejection fraction should be over 50% (Circ Heart Fail 2009;2: 105-112).
Incidence of CV mortality
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
ICD10 codes I00-I99
Incidence of nonfatal myocardial infarction
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
ICD10 codes I21,I22
Incidence of nonfatal heart failure
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
ICD10 code I50
Incidence of nonfatal stroke
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
ICD10 codes I60-I63
Incidence of CKD
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
ICD10 codes N17, N18
2 secondary outcomes
EQ-5D (scale ranging from 0 [worst possible] to 100 [best possible])
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years.
Health-economic analysis
Time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Derived from this study: PubMed 37147930Chori 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.
- Individual participant dataSharing planned: Yes. A motivated request for data transfer for scientific purposes should be addressed to Prof Jan A. Staessen
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lutgarde Thijs, MSc principal investigator
University of Leuven
12 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-vitro urinary diagnostic test in people with Protein Deregulation and Blood Pressure, run by KU Leuven at 12 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium, Poland, Denmark, Germany, Greece and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jan A Staessen, MD, PhD (+32 47 632 4928, jan.staessen@med.kuleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary composite endpoint (time frame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04299529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.