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New treatment option for Heart Failure and Chronic Kidney Disease Post-ICU
Official title Dapagliflozin for Cardio-renal Protection After ICU Discharge
ClinicalTrials.gov ID: NCT07025629
What this study is testing
What is Dapagliflozin 10 MG Oral Tablet [Farxiga]?
Dapagliflozin 10 MG Oral Tablet [Farxiga] is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for heart failure and chronic kidney disease post-icu.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- Pregnancy
- Ability to become pregnant and refusal to use effective contraception during all study treatment Women of childbearing potential (WOCBP)\ \ must...
- combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
- oral
- intravaginal
- transdermal
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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...
- 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 treatment study
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.