Dapagliflozin for Cardio-renal Protection After ICU Discharge

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT07025629
Phase
PHASE3
Status
Recruiting
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Conditions

  • Heart Failure and Chronic Kidney Disease Post-ICU

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Dec 2, 2025
Status verified
Jan 2026
Primary completion
Jan 15, 2029
Completion
Jan 15, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dapagliflozin
    One tablet of dapagliflozin 10 mg will be administered once daily from randomization and for 12 months period +/- 15 days..
  • Placebo Comparator: Placebo of dapagliflozin
    One tablet of placebo of dapagliflozin 10 mg will be administered, per os, once daily from randomization and for 12 months period ± 15 days.

Primary Outcome Measure

All-cause mortality [ Time Frame: Within the year after randomization ]

Central Contacts