A Multicenter, Randomized, Double-Blind, Parallel Group, Placebo-Controlled Trial to Evaluate the Effect of In-Hospital Initiation of Dapagliflozin on Clinical Outcomes in Patients Who Have Been Stabilized During Hospitalization for Acute Heart Failure
This research wants to find out if starting a medicine called dapagliflozin in hospital helps people who have recently been treated for acute heart failure. Acute heart failure makes your heart suddenly struggle to pump blood around your body effectively. The study will give some patients dapagliflozin and others a dummy pill (placebo) for two months. Neither the patients nor their doctors will know who is getting what. Researchers will then check if dapagliflozin can lower the chance of future heart issues, like needing more treatment for heart failure or being readmitted to hospital, or even death from heart problems. This is to see if starting the treatment early makes a real difference to patient health.
At a glance
What is this study about?
When your heart suddenly can't pump enough blood around your body, this is called acute heart failure. It can make you feel very unwell and often means you need to go into hospital for treatment. This study is designed to see if a particular medicine called dapagliflozin, when started while you are still in hospital but after your condition has stabilised, can help prevent future problems.
Researchers want to understand if starting this medicine early can reduce your chances of needing more treatment for heart failure in the future, being readmitted to hospital, or suffering other serious heart-related events. They will compare a group of patients who receive dapagliflozin with a group who receive a dummy pill, called a placebo. This helps them work out if any improvements are due to the new medicine or other factors.
This kind of research is really important because it helps doctors find the best ways to care for people with heart failure, aiming to improve their long-term health and quality of life. The study uses careful methods to make sure the results are reliable and can help inform future medical practice.
Key takeaways
- This study evaluates if starting dapagliflozin in hospital helps heart failure patients.
- It's for people recently hospitalised for acute heart failure and now stable.
- Participants take either dapagliflozin or a dummy pill for two months.
- The main goal is to see if the medicine prevents future heart problems.
- Participation involves taking daily medication and regular health checks.
Who may be eligible?
To take part in this study, you would need to be 18 years old or older. There is no upper age limit, meaning people of all adult ages can potentially join.
Both men and women are welcome to participate. The study is particularly looking for people who have recently been in hospital and had treatment for a sudden worsening of their heart failure, and whose condition is now stable.
While the basic requirements are straightforward, there will be more detailed health checks to make sure the study is a good fit for you and that it's safe for you to take part. This ensures the research is carried out responsibly and effectively.
- Are you 18 years old or older?
- Have you recently been in hospital for acute heart failure?
- Is your heart failure condition now stable after treatment?
- Are you willing to take a study medication daily for two months?
- Are you comfortable with regular health check-ups for a period?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would start taking a study medicine either dapagliflozin or a placebo (a dummy pill) by mouth once a day for two months, while you are still in hospital and after your heart failure has settled. Neither you nor your doctor would know which one you are taking.
Throughout the two months, and possibly for a longer period after that, the research team would monitor your health closely. This would involve regular check-ups, which might be in person or over the phone, to see how you are feeling and if you experience any changes. They would be looking for any signs of worsening heart failure, such as needing more treatment, going back into hospital, or having an urgent visit to your doctor for intravenous (IV) fluid medication.
Your involvement would help researchers understand the effects of starting this medicine early. The total duration of your active involvement with daily medication would be two months, but monitoring of your health outcomes would continue for a longer period.
Potential risks and benefits
Locations (3)
- —Poland
- —Hungary
- —Czechia
Common questions
What is acute heart failure?
Acute heart failure means your heart has suddenly become too weak to pump enough blood around your body, often requiring urgent medical attention and hospitalisation.
What is dapagliflozin?
Dapagliflozin is a medicine that has been shown to help people with heart failure by helping the body get rid of excess sugar and salt, which can ease the burden on the heart.
What is a 'placebo' in a study?
A placebo is a dummy pill that looks exactly like the study medicine but contains no active ingredients. It helps researchers fairly compare the medicine's effects.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'blinded' study, meaning neither you nor your doctors will know if you are receiving dapagliflozin or the placebo until the study is over. This helps ensure fair results.
How long would I need to take the study medicine?
If you join, you would take the study medicine (dapagliflozin or placebo) once a day for about two months.
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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