Study on Dapagliflozin for Heart and Kidney Health in Adults After ICU Discharge with Heart or Kidney Issues

1 1 1

What is this study about?

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.

1 joining the study

Participation begins after discharge from the intensive care unit (ICU).

Eligibility includes being 18 years or older, having received mechanical ventilation or certain medications for more than 24 hours, and meeting specific health criteria related to heart and kidney function.

2 medication administration

The study involves taking a medication called Forxiga (dapagliflozin) or a placebo, which is a tablet with no active medication.

The dosage is 10 mg, taken orally once a day.

The treatment continues for a duration of one year.

3 monitoring and follow-up

Health is monitored throughout the study to evaluate the effects of the medication on heart and kidney health.

Primary outcomes include overall survival, hospitalizations for heart failure, and changes in kidney function one year after ICU discharge.

Secondary outcomes include hospitalizations for cardiovascular events, changes in kidney function, and other health events during the treatment period.

4 safety evaluation

Safety is assessed by monitoring for specific health issues such as infections, diabetic complications, and low blood sugar levels.

Any serious health events are recorded and evaluated throughout the study period.

5 completion of study

The study concludes one year after the start of treatment, with a final evaluation of health outcomes.

The study is expected to end by January 16, 2028.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Centre Hospitalier Universitaire De Poitiers Poitiers France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis La Rochelle France
Centre Hospitalier De Perpignan Perpignan France
Centre Hospitalier D’Antibes Juan Les Pins Antibes France
Centre Hospitalier Bretagne Atlantique Vannes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Hqmsrzjz cpunsf Hcmge Myuock ik Acwckpsy Aurillac France
Carnox Hgqhnvbadzq Uthbtgceqpbnl Dh Dttdw Dijon France
Hkxaodll Ulemqnrxfmbtjn Sdrijsdlrs &zydvpu Hzhngji dl Hcgoyodqxib STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
02.12.2024

Trial locations

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.

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 ID:
2024-510941-32-00
Protocol code:
APHP220826
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Zenagamtide Compared with Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Croatia Germany Hungary Poland Portugal +1
  • Sacituzumab Tirumotecan in Recurrent or Metastatic Cervical Cancer After Platinum Chemotherapy and Anti-PD-L1 or Anti-PD-1 Therapy

    Recruiting

    1 1 1 1
    Austria Belgium Bulgaria Denmark Finland France +9