BridgeMD
Dapagliflozine for cardio-renal protection at ICU discharge
EU CTIS ID: 2024-510941-32-00
What this study is testing
To evaluate the benefit of Dapagliflozin on cardiovascular, renal and global outcome one year after ICU discharge in patients with increased cardiac and/or kidney biomarkers at ICU discharge.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age >or= 18 years
- Mechanical ventilation and/or vasopressors/inotropes for more than 24h during ICU
- 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 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
You likely can't join if
- Pregnancy or Breast feeding or Ability to become pregnant and refusal to use effective contraception during all study treatment
- Known hypersensitivity to dapagliflozin or any of the excipients
- Patients treated with dapagliflozin before ICU admission
- Patients with severe cirrhosis (Child-Pugh C)
- 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).
See the full eligibility criteria
- Age >or= 18 years
- Mechanical ventilation and/or vasopressors/inotropes for more than 24h during ICU
- 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 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
- Pregnancy or Breast feeding or Ability to become pregnant and refusal to use effective contraception during all study treatment
- Known hypersensitivity to dapagliflozin or any of the excipients
- Patients treated with dapagliflozin before ICU admission
- Patients with severe cirrhosis (Child-Pugh C)
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.