Taking people in FrancePhase 3

Dapagliflozin to Protect Heart and Kidneys After Intensive Care

Tests dapagliflozin against a placebo in adults leaving intensive care with heart or kidney problems.

Key facts

Who runs it: Assistance Publique - Hôpitaux de Paris
Where: Paris, FranceSee the 2 sites
Trial code: NCT07025629
Registry title: Dapagliflozin for Cardio-renal Protection After ICU Discharge
Status: Recruiting
Phase: Phase 3
People taking part: 600 people, planned
Started: 2 Dec 2025
Expected to end: 15 Jan 2029
Type of study: Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested: Dapagliflozin 10 MG Oral Tablet [Farxiga]
One tablet of placebo of dapagliflozin 10 mg
Record updated: 23 February 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults who needed machine breathing support or blood-pressure-raising drugs in intensive care for more than 24 hours and are ready to leave the ICU. It tests dapagliflozin against a placebo.

Age: 18 years or older
Sex: All sexes can join.
Disease stage: Needed mechanical ventilation and/or vasopressors/inotropes for more than 24 hours in the ICU, and ready for ICU discharge. At inclusion: NT-proBNP greater than 800 ng/L or BNP > 90 ng/L, and/or eGFR between 25 and 90 ml/min/1.73m².
Earlier treatment: People treated with dapagliflozin before ICU admission cannot join.
Biomarker or test result: NT-proBNP greater than 800 ng/L or BNP > 90 ng/L and/or eGFR between 25 and 90 ml/min/1.73m² (CKD-EPI formula) at inclusion.

Main reasons for not taking part

Pregnancy or breastfeeding
Allergy to dapagliflozin or its other ingredients
Severe cirrhosis (Child-Pugh C)
Urinary tract or perineal infection, or risk of skin infection near the perineum
Already needs dapagliflozin under guidelines (type 2 diabetes, symptomatic chronic heart failure, or certain chronic kidney disease)

The registry criteria, word for word

Show all 24 criteriaShow less

Who can take part

Age >or= 18 years
Mechanical ventilation and/or vasopressors/inotropes for more than 24h during ICU stay
Patients ready to be discharged from ICU according to physician in charge
Inform consent form signed by the patient
NT-proBNP greater than 800 ng/L or BNP > 90 ng/L and/or Estimated glomerular filtration rate (eGFR) between 25ml/min/1.73m² and 90ml/min/1.73m² of body-surface area (CKD-EPI formula) at inclusion

Who cannot take part

sexual abstinence; The above mentioned risk mitigation measures (contraception) should be maintained during treatment and until the end of relevant systemic exposure; ** a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy; A postmenopausal state is defined as no menses for 12 months without an alternative medical cause; A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient
Patients treated with dapagliflozin before ICU admission
Known hypersensitivity to dapagliflozin or any of the excipients
Patients who admitted or who developed during their ICU stay a urinary tract infection or a perineal infection and patients at risk of skin infection near the perineum (e.g., a sacral pressure ulcer)
Estimated glomerular filtration rate (eGFR) below 25 ml per minute per 1.73 m2 of body-surface area (CKD -EPI formula)
Patient for whom treatment with Dapagliflozine is strongly recommended according to recent international guidelines:; patients with type 2 diabetes mellitus adults for whom the treatment is inadequately controlled as an adjunct to diet and exercise: either as monotherapy when metformin is considered inappropriate due to inadequate tolerance, or in addition to other medications for the treatment of type 2 diabetes,; symptomatic chronic heart failure with reduced or preserved left ventricular ejection fraction,; chronic kidney disease, in addition to standard therapy with a glomerular filtration rate (GFR) between 25 and 75 mL/min/1.73m² and a urinary albumin-to-creatinine ratio (ACR) between 200 and 5000 mg/g and treated for at least 4 weeks with an ACE inhibitor or angiotensin 2 receptor blocker (ARB II or sartan)
Pregnancy
Ability to become pregnant and refusal to use effective contraception during all study treatment Women of childbearing potential (WOCBP)** must agree to use adequate contraception according to Recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG); The inclusion of WOCBP requires use of a highly effective contraceptive measure :
combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral; intravaginal; transdermal
progestogen-only hormonal contraception associated with inhibition of ovulation; oral; injectable; implantable
intrauterine device (IUD)
intrauterine hormone-releasing system ( IUS)
bilateral tubal occlusion
vasectomised partner
Breast feeding
Patients with severe cirrhosis (Child-Pugh C)
Patient without national health insurance, and patient on AME (state medical aid)
Persons deprived of liberty by a judicial or administrative decision
Participation in other interventional study

Where in France

Hospital Saint-LouisParis, FranceContact: François DEPRET, MD-PhDTaking people
Saint Louis HospitalParis, FranceContact: François DEPRET, MD-PHDNot yet recruiting

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

DapagliflozinExisting treatment, for comparison
One tablet of dapagliflozin 10 mg will be administered once daily from randomization and for 12 months period +/- 15 days..
Treatment: Dapagliflozin 10 MG Oral Tablet [Farxiga]
Placebo of dapagliflozinPlacebo, for comparison
One tablet of placebo of dapagliflozin 10 mg will be administered, per os, once daily from randomization and for 12 months period ± 15 days.
Treatment: One tablet of placebo of dapagliflozin 10 mg