RecruitingPhase 3NCT07025629

Dapagliflozin for Cardio-renal Protection After ICU Discharge

Dapagliflozin for Cardio-renal Protection After ICU Discharge: A Prospective, Randomized, Double Blinded, Multicenter Study: "DAPA-ICU Trial"


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

600 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Several millions of patients are admitted to ICUs in Europe or USA each year. We and others, have shown that patients discharged from intensive care units (ICU) have a high incidence of cardiovascular and/or renal events and high mortality rate (22%) during the year following ICU discharge. Furthermore, a very recent meta-analysis found an excess hazard of late cardiovascular events which persists for at least 5 years following hospital discharge in sepsis survivors. Hence, many international ICU societies recommended investigating and improving post-ICU outcome with scarce guidance. We demonstrated that the proportion of ICU patients dying or presenting cardiovascular events within the year following ICU discharge is reported \~25% \[2\], reaching \~40% in some studies when considering patients with acute kidney injury (AKI). Plasma biomarkers at ICU discharge have good predictive value and patients with increased kidney or cardiovascular biomarkers display high risk of such events. In addition, we and others demonstrated that AKI or sub-AKI (patient not meeting the AKI definition but with an increased kidney related biomarker) could induce remote cardio-vascular injury and fibrosis, which may be involved in the poor long-term prognosis of ICU-acquired AKI. We hypothesize that strategy that prevent worsening in cardiovascular and/or renal injuries and/or in cardiovascular consequences of sub-AKI and AKI after ICU discharge improve long-term outcomes in ICU survivors. SGLT2 inhibitors are widely recognized as key drugs to protect the kidney and/or the myocardium in chronic diseases such as diabetes or heart failure. Cardio protective effect of SGLT2 inhibitors is optimal in patients with higher cardiac biomarker.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called dapagliflozin (a medication used for diabetes and heart failure) can protect the heart and kidneys in patients who were recently discharged from the ICU after a serious illness. **You may be eligible if...** - You are 18 or older - You were on a mechanical ventilator or needed blood pressure medications in the ICU for more than 24 hours - You are ready to be discharged from the ICU - You have elevated heart stress markers in your blood (NT-proBNP or BNP) and/or mildly to moderately reduced kidney function **You may NOT be eligible if...** - You are pregnant or of childbearing potential and unwilling to use effective contraception during the study - You have certain other medical conditions that make this drug unsafe - You have very severe kidney failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDapagliflozin 10 MG Oral Tablet [Farxiga]

One tablet of dapagliflozin 10 mg will be administered once daily from randomization and for 12 months period +/- 15 days..

DRUGOne tablet of placebo of dapagliflozin 10 mg

One tablet of placebo of dapagliflozin 10 mg will be administered, per os, once daily from randomization and for 12 months period ± 15 days.


Locations(2)

Hospital Saint Louis

Paris, France

Saint Louis Hospital

Paris, France

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NCT07025629