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Heart Failure and Chronic Kidney Disease Post-ICUPhase 3DAPA-ICUNCT07025629

Dapagliflozin for Cardio-renal Protection After ICU Discharge

A Phase 3 study testing Dapagliflozin 10 MG Oral Tablet [Farxiga] in people with Heart Failure and Chronic Kidney Disease Post-ICU, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dapagliflozin 10 MG Oral Tablet [Farxiga]
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
600 participants
Where
2 sitesFrance
Study dates
2 Dec 2025to 15 Jan 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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
Show all 33Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

François DEPRET, MD-PHD contact

0142499570 ext. 0033

francois.depret@aphp.fr

Alexandre MEBAZAA, MD-PhD contact

01 49 95 80 85 ext. 0033

alexandre.mebazaa@aphp.fr

France2 sites, 2 recruiting

  • Hospital Saint Louis

    Paris, 75010

    François DEPRET, MD-PhD, 0142499570 ext. 0033, francois.depret@aphp.fr

    Recruiting

  • Saint Louis Hospital

    Paris, 75010

    François DEPRET, MD-PHD, 0142499570 ext. 0033, francois.depret@aphp.fr

    Alexandre Mebazaa, MD-PhD, 01 49 95 80 85 ext. 0033, alexandre.mebazaa@aphp.fr

    Not yet recruiting

Other trials in France

About this study

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

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.

Read the detailed description

Phase III study Prospective, multicenter, superiority, double-blind, randomized controlled study with two arms (1:1).

Every patient will be screened in the 48h before ICU discharge for trial inclusion and non-inclusion criteria until 72h hours after ICU discharge. After providing written informed consent, patients will be randomly assigned to receive either dapagliflozin (at a dose of 10 mg once daily) or matching placebo, in accordance with the sequestered, fixed-randomization schedule, with the use of balanced blocks to ensure an approximate 1:1 ratio of the two regimens for one year.

Four visits are planned, one at inclusion (V0), one at 6 months (V1), one at the end of the treatment (V2 at one year), one 6 weeks after the end of the treatment (V3, end of the study) and two phone calls at 3 (Phone call 1) and 9 months (phone call 2).

At 6 months (V1) and at 12 months (V2) visits, a clinical exam and biological analysis will be performed at hospital (i.e., HbA1c, glucose level, ionogram, NT-proBNP or BNP, serum creatinine, hematocrit and pregnancy urinary test) by anesthesiologists, cardiologists or nephrologists, to assess primary and secondary endpoints, including eGFR.

At 12 months + 6 weeks (V3) visit, a clinical exam and biological analysis will be performed at hospital (i.e., glucose level, NT-proBNP or BNP, serum creatinine) by anesthesiologists, cardiologists or nephrologists, to assess primary and secondary endpoints, including eGFR.

The phone calls, at 3 and 9 months, will be made by the designated persons and respecting the confidentiality and security of the data collected.

At inclusion (V0) and at 6 months (V1) the treatment will be deliver for the next 6 months. At 6 months (V1), the patient will pick up his treatment at the hospital.

Primary endpoints will be assessed at 6 and 12 months visit and phone calls (3 and 9 months).

Secondary endpoints will be assessed at each visit and phone calls (3, 6, 9, 12 and 12 + 6 weeks).

eGFR (glomerular filtration rate) will be assessed only at 6, 12 months and 12 + 6 weeks. The eGFR (glomerular filtration rate) will not be assessed at phone calls.

At each visit and phone calls, adverse events and severe adverse events will also be assessed.

Being tested
Dapagliflozin 10 MG Oral Tablet [Farxiga], One tablet of placebo of dapagliflozin 10 mg
Keywords
Cardiovascular outcomes, Renal outcomes, SGLT2 inhibitors, Cardiorenal syndrome, Critical illness recovery
Medical subject headings
Heart Failure, Cardio-Renal Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dapagliflozin 10 MG Oral Tablet [Farxiga]Drug

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

  • One tablet of placebo of dapagliflozin 10 mgDrug

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

Study groups in NCT07025629
Study groupRoleWhat they receive
DapagliflozinActive comparatorOne tablet of dapagliflozin 10 mg will be administered once daily from randomization and for 12 months period +/- 15 days..
Receives: Drug: Dapagliflozin 10 MG Oral Tablet [Farxiga]
Placebo of dapagliflozinPlacebo comparatorOne tablet of placebo of dapagliflozin 10 mg will be administered, per os, once daily from randomization and for 12 months period ± 15 days.
Receives: Drug: One tablet of placebo of dapagliflozin 10 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause mortality

    Measured: Within the year after randomization

  2. Unscheduled hospital hospitalization for heart failure

    All potential hospitalizations for heart failure should be recorded in the eCRF and submitted to adjudication. The Clinical Event Adjudication (CEA) committee members will adjudicate the events as specified in the (CEA) Charter.

    Measured: Within the year after randomization

  3. Decrease of eGFR by more than 50% from ICU discharge and/or end stage kidney disease defined as an eGFR<15ml/min/1.73m² and/or initiation of renal replacement therapy and/or kidney transplantation

    Dialysis, eGFR events (<15 mL/min/1.73m²; ≥50% decline in eGFR) will be recorded in the eCRF and submitted for adjudication.

    eGFR baseline is defined as the local laboratory value at inclusion visit. The eGFR will be calculated using CKD-EPI equation without race coefficient [87, 88].

    Measured: Within the year after randomization

Secondary outcomes (16)

  1. Unscheduled hospital hospitalization for acute heart failure

    Measured: Within the year after randomization

  2. Unscheduled hospital hospitalization for stroke

    Measured: Within the year after randomization

  3. Unscheduled hospital hospitalization for acute coronary syndrome

    Measured: Within the year after randomization

  4. Occurrence of severe chronic kidney disease

    Defined as eGFR <30 ml/min/1.73m2

    Measured: Within the year after randomization

  5. • Decrease of estimated glomerular filtration rate of more than 50% from baseline

    Measured: Within the year after randomization

  6. New episode of acute kidney injury (according to the KDIGO criteria) requiring hospitalization

    Measured: Within the year after randomization

  7. Occurrence of end stage kidney disease defined (eGFR<15ml/min/1.73m2) and/or initiation of renal replacement therapy and/or kidney transplantation

    Measured: Within the year after randomization

  8. Change in NT-proBNP (pg/mL) from baseline to end of study

    Measured: Between 12 months (end of treatment) and 12 months + 6 weeks (end of study)

  9. Occurrence of cardiovascular events

    The participants sites should record potential strokes and transit ischemic attacks (TIAs) in the eCRF and submit for adjudication. The CEA committee members will adjudicate all potential cerebrovascular events to decide if they qualify as stroke according to the criteria defined in the CEA charter

    Measured: Within the year after randomization

  10. Occurrence of renal events

    Measured: Within the year of treatment

  11. Urinary tract infection

    All potential events of urinary tract infection will be recorded in the eCRF and submitted to the CEA.

    Measured: Within the year after randomization

  12. Necrotizing fasciitis

    All potential events of necrotizing fasciitis will be recorded in the eCRF and submitted to the CEA.

    Measured: Within the year after randomization

  13. Symptomatic ketoacidosis

    This outcome is defined as Arterial pH <7.3 and Ketone-positive urine and Anion gap >10 mEq/L and Drowsy, stupor or coma All potential events of ketoacidosis will be recorded in the eCRF and submitted to the CEA.

    Measured: Within the year after randomization

  14. Major hypoglycaemia

    This outcome is defined as gycemia<3 mmol/l) and any episode of hypoglycemia for which assistance was needed, all potential major hypoglycaemia will be recorded in the eCRF and submitted to the CEA.

    Measured: Within the year after randomization

  15. Death of any cause

    Measured: Within the year after randomization

  16. Occurrence of global outcome events

    Events will be recorded in the eCRF and submitted to adjudication by the CEA committee for each event type. The adjudication process will ensure the thorough evaluation and classification of events based on the clinical and laboratory criteria specified in the study protocol.

    Measured: Within the year of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2025
  2. Study start2 Dec 2025
  3. Primary completion15 Jan 2029 (estimated)
  4. Study completion15 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups of participants will each receive different interventions.One group will receive dapagliflozin for the same amount of time that a second group will receive Placebo of dapagliflozin .
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07025629
Sponsor's protocol ID
APHP220826
Acronym
DAPA-ICU
Status last verified
Jan 2026
First submitted
12 May 2025
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) will be shared. The data will be anonymized to protect participants' privacy. Researchers may request access to the data by contacting the Steering Committee, which will review the request within two months. The data will be available one year after publication.

Publications

  • Sano M, Goto S. Possible Mechanism of Hematocrit Elevation by Sodium Glucose Cotransporter 2 Inhibitors and Associated Beneficial Renal and Cardiovascular Effects. Circulation. 2019 Apr 23;139(17):1985-1987. doi: 10.1161/CIRCULATIONAHA.118.038881. No abstract available.

    PubMed 31009585

  • Chang YK, Choi H, Jeong JY, Na KR, Lee KW, Lim BJ, Choi DE. Dapagliflozin, SGLT2 Inhibitor, Attenuates Renal Ischemia-Reperfusion Injury. PLoS One. 2016 Jul 8;11(7):e0158810. doi: 10.1371/journal.pone.0158810. eCollection 2016.

    PubMed 27391020

  • Zelniker TA, Wiviott SD, Raz I, Im K, Goodrich EL, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Furtado RHM, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS. SGLT2 inhibitors for primary and secondary prevention of cardiovascular and renal outcomes in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials. Lancet. 2019 Jan 5;393(10166):31-39. doi: 10.1016/S0140-6736(18)32590-X. Epub 2018 Nov 10.

    PubMed 30424892

  • Zannad F, Ferreira JP, Pocock SJ, Anker SD, Butler J, Filippatos G, Brueckmann M, Ofstad AP, Pfarr E, Jamal W, Packer M. SGLT2 inhibitors in patients with heart failure with reduced ejection fraction: a meta-analysis of the EMPEROR-Reduced and DAPA-HF trials. Lancet. 2020 Sep 19;396(10254):819-829. doi: 10.1016/S0140-6736(20)31824-9. Epub 2020 Aug 30.

    PubMed 32877652

  • Depret F, Hollinger A, Cariou A, Deye N, Vieillard-Baron A, Fournier MC, Jaber S, Damoisel C, Lu Q, Monnet X, Rennuit I, Darmon M, Leone M, Guidet B, Sonneville R, Montravers P, Pili-Floury S, Lefrant JY, Duranteau J, Laterre PF, Brechot N, Oueslati H, Cholley B, Struck J, Hartmann O, Mebazaa A, Gayat E, Legrand M. Incidence and Outcome of Subclinical Acute Kidney Injury Using penKid in Critically Ill Patients. Am J Respir Crit Care Med. 2020 Sep 15;202(6):822-829. doi: 10.1164/rccm.201910-1950OC.

    PubMed 32516543

  • Legrand M, Rossignol P. Cardiovascular Consequences of Acute Kidney Injury. N Engl J Med. 2020 Jun 4;382(23):2238-2247. doi: 10.1056/NEJMra1916393. No abstract available.

    PubMed 32492305

  • Gayat E, Cariou A, Deye N, Vieillard-Baron A, Jaber S, Damoisel C, Lu Q, Monnet X, Rennuit I, Azoulay E, Leone M, Oueslati H, Guidet B, Friedman D, Tesniere A, Sonneville R, Montravers P, Pili-Floury S, Lefrant JY, Duranteau J, Laterre PF, Brechot N, Chevreul K, Michel M, Cholley B, Legrand M, Launay JM, Vicaut E, Singer M, Resche-Rigon M, Mebazaa A. Determinants of long-term outcome in ICU survivors: results from the FROG-ICU study. Crit Care. 2018 Jan 18;22(1):8. doi: 10.1186/s13054-017-1922-8.

    PubMed 29347987

  • Arrigo M, Feliot E, Gayat E, Mebazaa A. Cardiovascular events after ICU discharge in patients with new-onset atrial fibrillation: A report from the FROG-ICU study. Int J Cardiol. 2018 Nov 1;270:203. doi: 10.1016/j.ijcard.2018.07.080. Epub 2018 Jul 20. No abstract available.

    PubMed 30045823

  • Depret F, Chousterman B, Roger C, Garnier M, Lalande R, Kerforne T, Rouve E, Lukaszewicz AC, Ouattara A, Merdji H, Turbil E, Bouhemad B, Quenot JP, Delbove A, Levrat Q, Jully M, Legriel S, Bougouin W, Klouche K, Kimmoun A, Asfar P, Vicaut E, Mebazaa A. Dapagliflozin for cardiorenal protection after intensive care unit discharge: a protocol for a randomised controlled trial evaluating dapagliflozin at ICU discharge for cardiorenal protection (DAPA-ICU). BMJ Open. 2026 Apr 16;16(4):e108119. doi: 10.1136/bmjopen-2025-108119.

    PubMed 41991273

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin 10 MG Oral Tablet [Farxiga] in people with Heart Failure and Chronic Kidney Disease Post-ICU, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact François DEPRET, MD-PHD (0142499570 ext. 0033, francois.depret@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause mortality (time frame: Within the year after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07025629, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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