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 range

55 Years – 75 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

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 range

55 Years – 75 Years

Sex

ALL

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