A 6-Month, Randomized, Double-Blind Study to Evaluate the Effect of Dapagliflozin on EChOcardiographic Measures of CarDiac StructurE and Function in Patients with Chronic Kidney Disease (DECODE-CKD)
This research study, called DECODE-CKD, is looking at how a treatment called dapagliflozin might help people who have chronic kidney disease. Chronic kidney disease means your kidneys aren't working as well as they should. The main thing the researchers want to find out is if this medicine can change the size and shape of the heart after six months. They'll use a type of scan called an echocardiogram, which is like an ultrasound for the heart, to measure this. The study will last six months and involve giving some participants dapagliflozin and others a dummy pill (placebo) that looks identical but contains no active medicine. This helps ensure fair results when comparing the two groups. Everyone taking part will be aged 18 or over.
At a glance
What is this study about?
This study is investigating a medicine called dapagliflozin in people who have chronic kidney disease. Chronic kidney disease means your kidneys are not working as well as they should, and this can sometimes affect other parts of your body, including your heart. We know that conditions like kidney disease can sometimes lead to changes in the heart's structure and how well it pumps blood around your body.
The main goal of this research is to see if dapagliflozin can help improve or prevent these heart changes over a six-month period. Specifically, the researchers will be looking at whether the medicine changes the size and thickness of the heart muscle, and how strongly the heart is pumping. They will use a special heart scan called an echocardiogram to get detailed pictures and measurements of the heart.
Understanding how dapagliflozin might affect the heart in people with kidney disease is really important. If the study shows that this medicine can protect or improve heart function, it could lead to better ways to care for people living with chronic kidney disease in the future. This research is in its early stages (Phase I and Phase II), which means it's testing for safety and also starting to look at how well the treatment works.
Key takeaways
- Study examines how dapagliflozin affects heart health in kidney disease.
- Goal is to see changes in heart size and pumping ability over 6 months.
- Uses heart scans (echocardiograms) for detailed measurements.
- Participants will receive either the study medicine or a dummy pill.
- Open to adults aged 18 and over with chronic kidney disease.
Who may be eligible?
To be part of this study, you need to be an adult, aged 18 years or older – there's no upper age limit. The study is open to both men and women.
Beyond these basic requirements, the research is specifically for people who have been diagnosed with chronic kidney disease. Your doctors will check other specific health details from your medical records to make sure the study is a good fit for you and that taking part would be safe.
Because this is a medical study, it's important that your overall health allows you to take part safely. The research team will review your health information carefully to see if you meet all the necessary criteria for joining.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a diagnosis of chronic kidney disease?
- Are you able to attend regular clinic visits for six months?
- Are you comfortable with blood tests and heart scans (echocardiograms)?
What does participation involve?
If you decide to join the study, you'll be involved for about six months. You would receive either the study medicine, dapagliflozin, or a dummy pill (placebo). The dummy pill looks exactly like the real medicine but contains no active ingredients, and neither you nor the study team will know which you are receiving – this is called a 'double-blind' study and helps make the results fair.
Throughout the six months, you would have several visits to the clinic for assessments. These will include regular check-ups, blood tests to measure things like kidney function and other health markers, urine tests, and heart scans called echocardiograms. These scans are like an ultrasound of your heart and will be used to see if there are any changes to your heart's size and how well it works. All these assessments help the researchers understand how the medicine is affecting your body. After the six-month treatment period, there will be a final check-up.
Potential risks and benefits
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Common questions
What is chronic kidney disease?
Chronic kidney disease means your kidneys aren't working as well as they should and are having trouble cleaning your blood properly.
What is an echocardiogram?
An echocardiogram is a type of scan that uses sound waves to create moving pictures of your heart. It helps doctors see its size, shape, and how well it's pumping blood.
What is dapagliflozin?
Dapagliflozin is a medicine that is already approved for some other conditions and is being studied here to see if it can help the heart in people with kidney disease.
What does 'double-blind' mean?
'Double-blind' means that neither you nor the doctors treating you will know if you are getting the active medicine or a dummy pill during the study. This helps ensure fair and unbiased results.
How long will I be in the study?
If you join this study, you will be involved for a total of six months, including the time for treatment and follow-up visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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