Clinical trial NCT04299529: Urinary Proteomics Combined With Home Blood Pressure Telemonitoring for Health Care Reform
Official title: Urinary Proteomics Combined With Home Blood Pressure Telemonitoring for Health Care Reform: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Protein Deregulation
Blood Pressure
Health Care Utilization
Cost Effectiveness
Patient Empowerment
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Alliance for the Promotion of Preventive Medicine
First posted: 2020-03-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group design
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Primary composite endpoint
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Change in serum creatinine (mg/dl)
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Change in eGFR (ml/min/1.73m2)
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Progression of CKD
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of diabetic nephropathy
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of diabetic retinopathy
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of hypertensive retinopathy
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of electrocardiographic LV hypertrophy
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of echocardiographic LV hypertrophy
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of diastolic LV dysfunction
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of CV mortality
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of nonfatal myocardial infarction
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of nonfatal heart failure
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of nonfatal stroke
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years
measure: Incidence of CKD
timeFrame: 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:
measure: EQ-5D (scale ranging from 0 [worst possible] to 100 [best possible])
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years.
measure: Health-economic analysis
timeFrame: After a run-in period of 2 to 5 weeks to check the eligibility, patients will be randomized and followed up for 4 years.
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: European Kidney Health Aliance
city: Gent
country: Belgium
facility: Diabetes Liga
city: Mechelen
country: Belgium
facility: Alliance for the Promotion of Preventive Medicine
city: Gentofte
country: Denmark
facility: Steno Diabetes Center Copenhagen
city: Hannover
country: Germany
facility: Mosaiques-Diagnoostics and Therapeutics AG
city: Athens
country: Greece
facility: Biomedical Research Foundation of the Academy of Athens
city: Abuja
country: Nigeria
facility: Department of Internal Medicine, Faculty of Clinical Sciences, College of Health Sciences, University of Abuja
city: Gdańsk
country: Poland
facility: Department of Hypertension, Medical University of Gdańsk
city: Kraków
country: Poland
facility: First Department of Cardiology, Interventional Electrocardiology and Hypertension, Jagiellonian University Medical College
city: Ljubljana
country: Slovenia
facility: Department of Internal Medicine, Division of Hypertension, University Medical Centre Ljubljana
city: Potchefstroom
country: South Africa
facility: Hypertension in Africa Research Team, Medical Research Council Unit for Hypertension and Cardiovascular Disease, North-West University
city: Montevideo
country: Uruguay
facility: Centro de Nefrología and Departamento de Fisiopatología, Hospital de Clínicas, Universidad de la República
Study officials:
affiliation: University of Leuven
name: Lutgarde Thijs, MSc
role: PRINCIPAL_INVESTIGATOR
References: