Effects of Continued Administration of Empagliflozin in Patients With Heart Failure on Active SGLT2 Inhibitor Treatment Admitted for Acute Decompensated Heart Failure
This study is investigating if it's better to keep taking the heart failure medicine empagliflozin (Jardiance) when you're already on it and get admitted to hospital because your heart failure has suddenly worsened. Currently, doctors sometimes stop this medication during such a hospital stay. The study aims to see if continuing empagliflozin is just as good, or even better, than pausing it. Participants will already be taking an SGLT2 inhibitor like empagliflozin before they join. They'll either keep taking 10mg of empagliflozin or a dummy pill (placebo) daily while in hospital and then everyone will take empagliflozin for 90 days after going home. Researchers will look at things like hospital stays for heart failure, kidney function, and deaths over 90 days, as well as how patients feel and how well their body gets rid of fluid.
At a glance
What is this study about?
This study is about people who have heart failure and are already taking a specific type of medication called an SGLT2 inhibitor (like empagliflozin, also known as Jardiance). When someone with heart failure suddenly gets worse and needs to go to hospital, doctors sometimes stop certain medications. This study wants to find out if it's safe and helpful to continue taking empagliflozin during this time, rather than stopping it. The main idea is to see if your health outcomes are just as good, or even better, if you keep taking the drug.
Heart failure means your heart isn't pumping blood as well as it should. When it gets "decompensated," it means your symptoms have suddenly worsened, often leading to more fluid in your body and a hospital stay. Empagliflozin is a drug that helps the heart and kidneys work better, and it's already used for long-term heart failure.
Researchers will compare two groups of patients: one group will continue taking empagliflozin, and the other will take a dummy pill (placebo) during their hospital stay. After leaving the hospital, everyone in the study will take empagliflozin. They will then track important health measures for 90 days, including whether people need to go back to hospital for heart failure, how their kidneys are working, and overall survival. They will also look at how much fluid your body gets rid of and how you feel in terms of quality of life.
Key takeaways
- This study aims to discover if continuing empagliflozin during a hospital stay for worsening heart failure is safe and beneficial.
- Participants must already be taking an SGLT2 inhibitor like empagliflozin before joining.
- The study compares continuing empagliflozin to taking a dummy pill (placebo) while in hospital.
- After hospital discharge, all participants will take empagliflozin for 90 days.
- Researchers will track important health outcomes like hospital admissions, kidney function, and survival.
Who may be eligible?
To join this study, people need to be at least 18 years old and have been admitted to hospital because their heart failure has suddenly become worse. An important point is that you must already be taking an SGLT2 inhibitor, which is a specific type of heart failure medication (like empagliflozin).
There are also some reasons why you wouldn't be able to join. For example, if you have type 1 diabetes, severe kidney problems, a known allergy to empagliflozin, or if your heart failure is serious but without signs of fluid build-up. Also, if you need urgent heart procedures or treatments, or have specific medical conditions like acute coronary syndrome, you wouldn't be able to take part.
Women who could become pregnant would need to have a negative pregnancy test and use very effective contraception. People who are pregnant or breastfeeding cannot join. You also need to be able to understand what the study involves and agree to take part.
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 at least 18 years old?
- Have you been admitted to hospital recently because your heart failure got worse?
- Are you currently taking an SGLT2 inhibitor, like empagliflozin (Jardiance)?
- Do you *not* have severe kidney disease or require dialysis?
- Are you able to understand the study and provide written consent?
What does participation involve?
If you join this study, you will:
* **Take medication:** You will take one tablet every day for 90 days. For the first part, while in hospital, you'll either receive empagliflozin or a dummy pill. After discharge (and no later than day 31), you'll take empagliflozin daily until day 90. * **Fluid intake:** You'll be asked to limit your fluid intake to around 1.5 litres (about 6 cups) per day and record how much you drink for the first 6 days. * **Measure urine output:** For the first 6 days, you'll also need to measure and record how much you wee each day. * **Fill in questionnaires:** You'll complete questionnaires about your quality of life (how you feel generally and about your heart failure) at the start of the study, when you leave hospital, and again on day 30. * **Follow-up:** The study will track your health for 90 days after you are admitted to hospital.
Potential risks and benefits
Locations (9)
- Jena University HospitalVerified postcodeJena, Germany· Recruiting
- Kerckhoff-Klinik GmbHVerified postcodeBad Nauheim, Germany· Recruiting
- Herzzentrum Dresden GmbH UniversitaetsklinikVerified postcodeDresden, Germany· Not yet recruiting
- Universitaetsmedizin GoettingenVerified postcodeGöttingen, Germany· Not yet recruiting
- Universitaetsklinikum Leipzig AöRVerified postcodeLeipzig, Germany· Recruiting
- Herzzentrum Leipzig GmbHVerified postcodeLeipzig, Germany· Not yet recruiting
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRVerified postcodeMainz, Germany· Not yet recruiting
- LMU Klinikum Muenchen AöRVerified postcodeMünchen, Germany· Not yet recruiting
- Rostock University Medical CenterVerified postcodeRostock, Germany· Not yet recruiting
Common questions
What is 'acute decompensated heart failure'?
It means your heart failure symptoms have suddenly worsened, often leading to more fluid in your body and needing hospital care.
What is empagliflozin (Jardiance)?
It's a medication for heart failure that helps your heart and kidneys work better. It's also used for diabetes.
Will I know if I'm getting the real drug or a dummy pill?
No, it's a 'blinded' study, meaning neither you nor your doctors will know which you are receiving during your hospital stay, to ensure fair results.
How long will I be in the study?
You will take medication and be monitored for a total of 90 days from your hospital admission date.
What is an SGLT2 inhibitor?
It's a type of medication that helps the kidneys remove sugar and salt from your body, which can benefit people with heart failure and kidney disease.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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