Centre Hospitalier De Versailles
Le Chesnay-Rocquencourt, France
RecruitingLaboratory test abnormal
Study on Dapagliflozin for Heart and Kidney Health in Adults After ICU Discharge with Heart or Kidney Issues
Verified siteRegistered drug
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
What is this trial about?
A plain-language summary of the goals, design and what participants do
This clinical trial is focused on patients who have been discharged from the Intensive Care Unit (ICU) and are experiencing certain heart and kidney issues. Specifically, it involves adult patients who have a decreased estimated glomerular filtration rate (eGFR), which is a measure of kidney function, and/or have had an acute kidney injury (AKI) during their ICU stay, and/or have elevated levels of a heart-related protein called NT-proBNP at the time of discharge. The study aims to evaluate the effects of a medication called dapagliflozin, which is marketed under the name Forxiga, on heart and kidney health one year after ICU discharge.
Participants in the study will be randomly assigned to receive either Forxiga or a placebo, which looks like the medication but does not contain the active ingredient. The purpose of the study is to assess whether Forxiga can improve outcomes related to heart and kidney health, such as reducing the risk of heart failure, preventing a significant decline in kidney function, and improving overall survival rates one year after leaving the ICU. The study will be conducted over a period of one year, during which participants will be monitored for any changes in their health status.
The trial will also track any hospitalizations due to heart or kidney issues, as well as any serious side effects that may occur. This includes monitoring for conditions like severe chronic kidney disease, new episodes of acute kidney injury, and other cardiovascular events. Safety will be a key focus, with attention given to potential side effects such as urinary tract infections, diabetic ketoacidosis, and major hypoglycemia. The study aims to provide valuable information on the potential benefits of Forxiga for patients recovering from serious health conditions after an ICU stay.
The research process
The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.
Who can join the trial?
5 criteria
- Must be an adult, aged 18 years or older.
- Must have been on a breathing machine (mechanical ventilation) or received medications to support blood pressure (vasopressors/inotropes) for more than 24 hours while in the Intensive Care Unit (ICU).
- Must be ready to leave the ICU, as determined by the doctor in charge.
- Must have signed a form agreeing to participate in the study (informed consent form).
- Must have a level of NT-proBNP, a heart-related marker, greater than 800 ng/L, and/or an estimated glomerular filtration rate (eGFR), which measures kidney function, between 25 and 90 ml/min/1.73m² of body-surface area at the time of joining the study.
Who cannot join the trial?
7 criteria
- Patients who are not adults cannot participate.
- Patients who have not been discharged alive from the Intensive Care Unit (ICU) cannot participate.
- Patients without a decreased estimated Glomerular Filtration Rate (eGFR) cannot participate. The eGFR is a test that checks how well the kidneys are working.
- Patients who did not experience an Acute Kidney Injury (AKI) during their ICU stay cannot participate. AKI is a sudden decrease in kidney function.
- Patients without elevated NT-proBNP levels at discharge cannot participate. NT-proBNP is a substance that the heart releases when it is under stress.
- Patients who are not male or female cannot participate.
- Patients who are part of a vulnerable population cannot participate. This means people who might need extra protection or care.
Clinical Trials Concierge
Prefer not to search? Our Concierge searches the trials for you.
Tell us about your condition – we search every trial in Europe and connect you with the right site.
We usually reply within a few days
Verified sites
All sites with verified contact details – recruitment status may not be available; ask directly
Verified Verified Centre Hospitalier Lyon Sud
Pierre Benite, FranceVerified Centre Hospitalier Universitaire De Bordeaux
Bordeaux, France
Trial locations
Where you can join this trial
Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.
RecruitingNot finding your country?
Not sure what to do next?
Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.
Investigated drugs
Dapagliflozin is a medication used in this trial to assess its potential benefits for heart and kidney health after a patient is discharged from the Intensive Care Unit (ICU). It is being studied to see if it can improve outcomes for patients who have high levels of certain heart and kidney markers when they leave the ICU.
What is already known about the treatment
Dapagliflozin – Dapagliflozin is administered orally in tablet form. It is currently being studied in clinical trials for its potential benefits in patients discharged from the ICU with certain heart and kidney conditions. The main therapeutic indications include improving cardiovascular and renal outcomes in these patients. At the molecular level, dapagliflozin works by inhibiting a protein in the kidneys called sodium-glucose co-transporter 2 (SGLT2), which helps reduce blood sugar levels and may also have protective effects on the heart and kidneys. It is classified as an SGLT2 inhibitor, a type of medication primarily used to manage type 2 diabetes.
Investigated diseases
Acute Kidney Injury
This condition occurs when the kidneys suddenly become unable to filter waste products from the blood. It can develop rapidly over a few hours or days and is often seen in patients who have been critically ill or hospitalized. The accumulation of waste products can lead to an imbalance of fluids and electrolytes in the body. Symptoms may include decreased urine output, swelling due to fluid retention, and fatigue. If not addressed, it can lead to more severe kidney damage.
Chronic Kidney Disease
This is a long-term condition where the kidneys gradually lose their function over time. It often progresses slowly and may not show symptoms until significant damage has occurred. As the disease advances, waste products can build up in the blood, leading to complications such as high blood pressure, anemia, and weak bones. Patients may experience symptoms like fatigue, swelling in the legs, and changes in urination patterns. Monitoring and managing the condition is crucial to slow its progression.
Heart Failure
This condition occurs when the heart is unable to pump blood effectively to meet the body's needs. It can develop gradually or suddenly and is often a result of other heart conditions such as coronary artery disease or high blood pressure. Symptoms include shortness of breath, fatigue, and swelling in the legs and abdomen. As the condition progresses, it can lead to more severe symptoms and complications, affecting the quality of life.
Diabetic Ketoacidosis
This is a serious complication of diabetes that occurs when the body starts breaking down fats at a rapid rate, producing ketones, which are then released into the blood. It is often triggered by a lack of insulin and can lead to symptoms such as excessive thirst, frequent urination, nausea, and confusion. If not treated promptly, it can lead to severe dehydration and other complications.
Necrotizing Fasciitis
This is a rare but severe bacterial infection that destroys the body's soft tissue. It can spread rapidly and requires immediate medical attention. Symptoms often start with sudden pain and swelling in the affected area, followed by fever and skin changes. The condition can progress quickly, leading to severe tissue damage and systemic symptoms.
Hypoglycemia
This condition occurs when blood sugar levels drop below normal, often due to excessive insulin or inadequate food intake. Symptoms can include shakiness, sweating, confusion, and irritability. If not addressed, it can lead to more severe symptoms such as seizures or loss of consciousness. It is important for individuals with diabetes to monitor their blood sugar levels to prevent episodes of hypoglycemia.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510941-32-00Protocol codeAPHP220826Estimated enrolment600 patientsSponsorAssistance Publique Hopitaux De Paris
sourced from the EU Clinical Trials Register and site verification
Want to learn more about this trial or check if you can participate?