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Starting soon Not applicable

Implementation Trial In patieNts With rEnal failuRe and diAbetes for Major Adverse reNal and Cardiovascular Events

NCT07634718 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-06
Last updated
2026-06-09

Condition(s) studied

DiabetesRenal Failure , Chronic

Investigational drug(s) / intervention(s)

Health-related messages

Health-related messages: Patient will be included in the intervention according to the laboratory's randomization arm.The intervention consists in delivering patient information messages in laboratory reports, providing access to an educational video for patients and a specific message for the prescribing physician in the intervention arm, without modifying patient care.

Study summary

The goal of this clinical study is to establish if the use of public health-related messages, designed and disseminated to a targeted population, will result in tangible improvements in patient outcomes and healthcare practices.

Specific health-related messages oriented towards patients, through their biological results and HealthCare Professionals (HCPs), will be sent to participants included in the intervention group. The control group will not receive any health-related message (routine care).

The aim is to evaluate if this intervention leads to differences in Major Adverse Renal and Cardiovascular Events (MARCE), compared to routine care (no dissemination of health messages) in patients suffering in diabetes and renal failure.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Main inclusion criteria: * Subject attending a ML participating to the study * Subject presenting a HbA1c ≥ 6.5% and an estimated GFR (CKD-EPI formula) in the range 60 to 15 ml/min (included) and/or albumin to creatinine ratio ≥ 300 mg albumin/g creatinine (or 30 mg/mmol creatinine), on the same biological determination. Main exclusion criteria: * Subject previously identified as opposed to the use of their medical data and/or access of their SNDS data, * Subject not registered to the French social security system, * Subject with estimated GFR \< 15 ml/min on the day of inclusion

Primary outcome measure(s)

  • Major Adverse Renal and Cardiovascular Events (MARCE) occurrence — 2 years after randomization and dissemination of health-related messages
    Change in Major Adverse Renal and Cardiovascular Events (MARCE) occurrence defined as a composite outcome including the following items (first occurring): * All-cause death * Myocardial infarction (universal definition) * Stroke (universal definition) * Sustained (over 45 days) use of renal replacement therapy * Heart failure leading to hospitalization (definition by the European Society of Cardiology)

Trial sites (1)

FacilityCityRegionStatus
Biogroup laboratories Nantes France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07634718 on ClinicalTrials.gov ↗ ← All trials in France