SGLT2 INHIBITION (DAPAGLIFLOZIN) IN DIABETIC AND NON-DIABETIC HEMODIALYSIS PATIENTS WITH AND WITHOUT RESIDUAL URINE VOLUME: A PROSPECTIVE RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED PHASE II TRIAL
This research trial is looking into a medication called dapagliflozin, also known as Forxiga. It's for adults with chronic kidney disease who are currently receiving haemodialysis, regardless of whether they have diabetes or not. The main goal is to see if this medicine can help to reduce a condition where the heart muscle becomes thickened, known as Left Ventricular Hypertrophy, after six months. This is an important trial because heart problems are common in people with kidney failure. Participants will either receive the study drug or a dummy pill (placebo) in a way that neither they nor their doctors will know which one they are taking. We'll also be checking various other health markers, including blood sugar, blood pressure, and general quality of life.
At a glance
What is this study about?
This study is testing a medicine called dapagliflozin (also known as Forxiga) in people who have serious kidney disease and are on dialysis. When kidneys don't work properly, it can put a strain on the heart, making its main pumping chamber (the left ventricle) grow thicker. This condition, called Left Ventricular Hypertrophy, is a common problem for people on dialysis and can lead to more serious heart issues. We want to find out if dapagliflozin can help reduce this thickening of the heart muscle.
Dapagliflozin is already used for certain conditions like diabetes and heart failure, but we need to understand if it can also help people on dialysis, especially regarding their heart health. The study aims to look at how much the heart muscle thickness changes over six months in people taking the medicine compared to those taking a dummy pill.
By taking part, you could help doctors learn more about how to protect the hearts of people with severe kidney disease. This is a "Phase II" study, which means it's an early stage of testing to see if the treatment is promising and safe enough for larger studies in the future. The information gathered from this research could eventually lead to better treatments for people like you.
Key takeaways
- This study investigates a heart-protective medicine for people on dialysis.
- It aims to reduce heart muscle thickening (Left Ventricular Hypertrophy).
- Both diabetic and non-diabetic adults on dialysis can participate.
- Participants will receive either the drug (Forxiga) or a harmless dummy pill.
- The study lasts for six months of treatment and monitoring.
Who may be eligible?
This study is looking for adult participants, meaning anyone aged 18 years or older. Both men and women can take part in this research.
To be eligible, you must have chronic kidney disease and be receiving haemodialysis treatment. The study is open to people who have diabetes and those who do not.
More specific details about your health and current medications would be checked by the study team to make sure it's safe for you to participate.
- Are you 18 years old or older?
- Do you have chronic kidney disease?
- Are you currently receiving haemodialysis?
- Are you male or female?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, it will involve taking either the study medicine (dapagliflozin) or a dummy pill (placebo) every day for six months. These look identical, and neither you nor your study doctor will know which you are receiving, which helps us get the most accurate results. You will have regular visits to the clinic so the study team can monitor your health closely, including checking your heart, blood, and other measurements.
These visits will involve assessments like blood tests to check your blood sugar, kidney function, and heart markers, as well as blood pressure readings and possibly heart scans to measure the thickness of your heart muscle. We will also ask you to complete questionnaires about your quality of life. The total duration of your active participation, including taking the medication and follow-up checks, will be six months. There may be some additional follow-up after the treatment period.
Potential risks and benefits
Locations (1)
- —Austria
Common questions
What is Left Ventricular Hypertrophy?
It's when the main pumping chamber of your heart gets thicker than it should, often due to strain, and it's common in people with kidney disease.
What is a placebo?
A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps us see if the medicine really works.
What is haemodialysis?
Haemodialysis is a treatment that filters waste products and extra fluid from your blood when your kidneys can no longer do it.
Will I know if I'm getting the real medicine?
No, neither you nor your study doctor will know if you are getting the active medicine or the placebo. This is to ensure fair and accurate results.
How long will I be in the study?
You will be actively involved in the study, including taking the medication, for six months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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