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Study on the Effects of Dapagliflozin on Heart Function in Patients with Chronic Kidney Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called dapagliflozin on patients with chronic kidney disease (CKD). Chronic kidney disease is a condition where the kidneys are damaged and cannot filter blood as well as they should. The study aims to understand how dapagliflozin affects the heart's structure and function in these patients. Dapagliflozin is a medication that is often used to help control blood sugar levels in people with diabetes, but this study is exploring its potential benefits for the heart in people with CKD.

The study will last for six months and will involve participants taking either dapagliflozin or a placebo, which looks like the medication but does not contain the active ingredient. Throughout the study, participants will undergo tests to measure changes in their heart's structure and function using a method called echocardiography, which is a type of ultrasound for the heart. Other health markers, such as those related to the kidneys, metabolism, and inflammation, will also be monitored.

The purpose of this study is to provide a comprehensive view of how dapagliflozin might help improve heart health in people with chronic kidney disease. By the end of the study, researchers hope to gather valuable information that could lead to better treatment options for patients with CKD. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being throughout the trial.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Randomization and initial visit
Upon joining the study, you will be randomly assigned to receive either the medication dapagliflozin or a placebo. A placebo looks like the real medication but does not contain the active ingredient.
During this visit, you will undergo initial assessments, including an echocardiogram, which is an ultrasound of the heart, to measure your heart's structure and function.
Step 2
Medication administration
You will take the assigned medication orally once a day. If you are in the dapagliflozin group, you will receive the active medication. If you are in the placebo group, you will receive a pill that looks the same but does not contain the active ingredient.
The duration of the medication administration is 6 months.
Step 3
Monthly follow-up visits
You will have monthly follow-up visits to monitor your health and the effects of the medication. These visits will include assessments of your heart and kidney function, as well as other health checks.
During these visits, you may also be asked to provide blood and urine samples for further analysis.
Step 4
Final assessment
At the end of the 6-month period, you will have a final assessment. This will include another echocardiogram to evaluate any changes in your heart's structure and function.
Additional tests may be conducted to assess changes in various health markers, including cardiac, renal, and metabolic biomarkers.

Who can join the trial?

8 criteria

Signed informed consent: You must agree to participate in the study by signing a consent form.
18 years of age or older: You must be at least 18 years old.
For those not on dialysis: You must have Chronic Kidney Disease (CKD), which means your kidneys are not working as well as they should. This is shown by a specific test result called eGFR (estimated Glomerular Filtration Rate) that is between 20 and 60, or by having a condition called albuminuria (protein in your urine) for more than 3 months if your eGFR is above 60.
For those on hemodialysis: You must have started hemodialysis (a treatment to clean your blood) within 1 year before joining the study.
Stable treatment with appropriate doses of ACE inhibitors (ACEi) or Angiotensin Receptor Blockers (ARB) if you have CKD with protein in your urine, unless your doctor advises against it.
For patients with type 2 diabetes: You must have been on a stable diabetes treatment for more than 30 days before joining the study.
Female patients: If you can have children, you must use a reliable method of birth control during the study and for 30 days after it ends. This can include hormonal methods (like the pill, implant, injection, patch, or ring) or an intrauterine device (IUD). If you cannot have children, you must be postmenopausal for at least 1 year or have had surgery to prevent pregnancy.
Ability to understand and read Danish: You must be able to read and understand the Danish language.

Who cannot join the trial?

10 criteria

Patients with a history of severe allergic reactions to the study medication cannot participate.
Individuals with uncontrolled high blood pressure are excluded. This means their blood pressure is not managed well with medication or lifestyle changes.
Patients with active infections that require treatment are not eligible.
Those with a history of heart attack or stroke in the last 6 months cannot join the study.
Individuals with severe liver disease are excluded. This refers to serious liver problems that affect its function.
Pregnant or breastfeeding women cannot participate in the study.
Patients currently participating in another clinical trial are not eligible.
Individuals with a history of drug or alcohol abuse in the past year are excluded.
Patients with certain types of cancer, except for skin cancer that is not melanoma, cannot join the study.
Individuals with a history of organ transplant are not eligible.

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Verified sites

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Gentofte Hospital
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Hellerup, Denmark
Herlev Hospital
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Herlev, Denmark

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Investigated drugs

Dapagliflozin is a medication used in this clinical trial to help understand its effects on the heart's structure and function in patients with chronic kidney disease. It works by helping the kidneys remove glucose from the bloodstream through urine. This can help lower blood sugar levels and may have additional benefits for the heart and kidneys. In this study, researchers are looking at how dapagliflozin might change the heart's size and how well it pumps blood in people with different stages of chronic kidney disease.

Dapagliflozin Propanediol

What is already known about the treatment

Dapagliflozin – Dapagliflozin is a medication taken orally, usually in the form of a tablet. It is currently being studied for its effects on heart structure and function in patients with chronic kidney disease. The main therapeutic use of dapagliflozin is to help manage chronic kidney disease by potentially improving heart function. At the molecular level, dapagliflozin works by inhibiting a protein in the kidneys called SGLT2, which helps reduce blood sugar levels and may have beneficial effects on the heart and kidneys. It is classified as an SGLT2 inhibitor, a type of drug that helps control blood sugar levels in people with diabetes and may have additional benefits for heart and kidney health.

Investigated diseases

Chronic kidney disease – Chronic kidney disease is a long-term condition characterized by a gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, individuals may experience symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. The progression of chronic kidney disease can lead to complications such as high blood pressure, anemia, and bone disease. Over time, the kidneys may lose their ability to function adequately, requiring interventions to manage the condition. The disease can affect individuals of all ages and is often associated with other health conditions like diabetes and hypertension.