Not Yet RecruitingNot Applicable

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

Belgium, Denmark, Germany1,000 participantsStarted 2020-04-01

Plain-language 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

Who can participate

Age range55 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

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

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

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

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

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

Trial details

NCT IDNCT04299529

SponsorKU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Jan A Staessen, MD, PhD

+32 47 632 4928 jan.staessen@med.kuleuven.be

View on ClinicalTrials.gov More Protein Deregulation trials

Who can participate

Age range55 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

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

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

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

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

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

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