Dapagliflozin to protect the heart and kidneys after ICU discharge
Dapagliflozin for Cardio-renal Protection After ICU Discharge: A Prospective, Randomized, Double Blinded, Multicenter Study: "DAPA-ICU Trial"
We will test whether taking dapagliflozin for one year after leaving the ICU reduces later heart and kidney complications in adults who had severe critical illness.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT07025629 on ClinicalTrials.gov |
What this trial studies
This is a Phase III, multicenter, double-blind, randomized placebo-controlled trial enrolling adults ready for ICU discharge who required mechanical ventilation or vasopressor support for more than 24 hours. Eligible patients with elevated NT‑proBNP/BNP or reduced eGFR will be randomized 1:1 to dapagliflozin 10 mg once daily or matching placebo and treated for one year. Participants will be screened within 48 hours before to 72 hours after ICU discharge and followed with clinic visits at 6 and 12 months plus a post-treatment visit and two interim phone calls to monitor events, labs, and safety. Primary outcomes include major cardiovascular and renal events and serial measures of kidney function such as eGFR.
Who should consider this trial
Good fit: Adults (≥18) who required mechanical ventilation and/or vasopressors for more than 24 hours, are ready for ICU discharge, can give informed consent, and have NT‑proBNP >800 ng/L or BNP >90 ng/L and/or an eGFR between 25 and 90 mL/min/1.73 m2.
Not a fit: Patients with very low kidney function (eGFR <25 mL/min/1.73 m2), pregnant women, or those without elevated cardiac/renal biomarkers are either ineligible or unlikely to gain benefit from this intervention.
Why it matters
Potential benefit: If effective, dapagliflozin could reduce heart failure events, major cardiovascular complications, and slow kidney decline in high‑risk ICU survivors.
How similar studies have performed: Large randomized trials have shown dapagliflozin and other SGLT2 inhibitors improve outcomes in heart failure and chronic kidney disease, but applying this therapy specifically to post‑ICU survivors is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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. * Breast feeding * Known hypersensitivity to dapagliflozin or any of the excipients * Patients treated with dapagliflozin before ICU admission * Patients with severe cirrhosis (Child-Pugh C) * 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). * 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 this trial is running
Paris and 1 other locations
- Hospital Saint Louis — Paris, France (Recruiting)
- Saint Louis Hospital — Paris, France (Not_yet_recruiting)
Study contacts
- Principal investigator: Alexandre Mebazaa, MD-PHD — Aphp
- Study coordinator: François DEPRET, MD-PHD
- Email: francois.depret@aphp.fr
- Phone: 0142499570
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.