Real-world Study on Dapagliflozin Usage in Patients With Heart Failure (HF) in Germany
This study is about a medicine called dapagliflozin, which is approved to treat heart failure. Heart failure is a condition where your heart doesn't pump blood as well as it should, affecting many people worldwide. Doctors want to understand how dapagliflozin is being used in Germany in real life, outside of strict clinical trials. They will look at how it helps people with their heart failure symptoms, their overall health and well-being, and how often they need to see a doctor. The goal is to see how well this treatment works for people with different types of heart failure, including those with or without diabetes.
At a glance
What is this study about?
Imagine your heart is like a pump that keeps your blood moving around your body. Heart failure means this pump isn't working as efficiently as it should, which can make you feel tired or breathless. It's a common condition that affects many people, and it can have a big impact on their daily lives.
A new medicine called dapagliflozin has recently been approved in Europe to help people with heart failure. What's interesting is that it can help whether someone also has diabetes or not, and regardless of how well their heart muscle squeezes.
This study isn't a traditional experiment where doctors give people new medicines. Instead, it's a 'real-world' study. This means researchers are observing people who are already being treated with dapagliflozin for their heart failure by their own doctors in Germany. They want to see how the medicine is used in everyday situations and how it affects people's symptoms, their overall health and quality of life, and their healthcare needs. This kind of study helps doctors understand how treatments work in normal healthcare settings.
Key takeaways
- This study looks at how a heart failure medicine called dapagliflozin is used in everyday life.
- It helps doctors understand how the medicine affects symptoms and quality of life.
- You must already be taking dapagliflozin for heart failure to join.
- The study takes place in Germany and focuses on real-world treatment.
- Your medical care will not change if you participate in this study.
- Your information helps improve understanding of heart failure treatment for others.
Who may be eligible?
To join this study, you need to be at least 18 years old and have started taking dapagliflozin for your heart failure. You would have started this medicine within the last 14 to 90 days.
Your heart failure treatment with dapagliflozin must be in line with what's approved for heart failure in Germany. This includes people with different types of heart failure, whether their heart muscle squeezes normally or not so strongly.
You wouldn't be able to join if you've already taken dapagliflozin or similar medicines before, or if you started dapagliflozin outside of the approved reasons for heart failure. Also, if you have Type 1 diabetes, are allergic to dapagliflozin, or are taking part in another heart failure study, you wouldn't be suitable. Finally, if you're involved in planning or running this particular study, you can't participate.
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?
- Have you started taking dapagliflozin for heart failure in the last 14 to 90 days?
- Is your heart failure being treated with dapagliflozin according to approved guidelines?
- Do you have Type 1 diabetes (if yes, you can't join)?
- Are you currently in another study testing a new heart failure medicine (if yes, you can't join)?
What does participation involve?
If you join this study, it's mainly about sharing information about your existing treatment. You won't be given new medicine or asked to do anything different from what your doctor has already prescribed. The research team will collect information about your heart failure symptoms, how you feel day-to-day, and any healthcare you've received. This information will come from your medical records and possibly some questionnaires about your health and quality of life. The exact number of visits or assessments will depend on how your doctor continues to manage your care, as the study observes your regular treatment over a period of time.
Potential risks and benefits
Locations (47)
- Research SiteVerified postcodeAachen, Germany
- Research SiteVerified postcodeAlsfeld, Germany
- Research SiteVerified postcodeBamberg, Germany
- Research SiteVerified postcodeBechhofen, Germany
- Research SiteVerified postcodeBergisch Gladbach, Germany
- Research SiteVerified postcodeBerlin, Germany
- Research SiteVerified postcodeBerlin, Germany
- Research SiteVerified postcodeBrilon, Germany
- Research SiteVerified postcodeBruchsal, Germany
- Research SiteVerified postcodeChemnitz, Germany
- Research SiteVerified postcodeDinslaken, Germany
- Research SiteVerified postcodeErfurt, Germany
Common questions
What is dapagliflozin?
Dapagliflozin is a medicine approved to help treat heart failure. It helps the heart work better.
Will I have to take a new medicine?
No, this study is for people already taking dapagliflozin as prescribed by their doctor. You won't be given any new medicine.
Will this study change my current treatment plan?
No, your doctor will continue to manage your heart failure treatment as usual. The study just collects information about your ongoing care.
Is the study open to people with or without diabetes?
Yes, dapagliflozin is approved for heart failure in people both with and without diabetes, and the study includes both.
How long does the study last for me?
The study observes your treatment over time. Your participation will depend on how long your doctor continues your treatment and how long the researchers need to collect information.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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