Active not recruitingOBSERVATIONAL

Pharmacokinetics of Bisoprolol and SGLT2i in Acutely Decompensated Heart Failure

This study is investigating how certain heart failure medications, bisoprolol and SGLT2 inhibitors (which include dapagliflozin and empagliflozin), act in the body of people who have active, worsening heart failure. We don't fully understand how these drugs work when someone's heart failure suddenly gets worse, compared to when it's more stable. The aim is to gather information on how these medicines are processed by the body (pharmacokinetics) and what effects they have (pharmacodynamics) during this time. This will help doctors understand if current treatment guidelines are still suitable and if dosage recommendations might need to be adjusted for patients with this condition, ensuring treatments are as safe and effective as possible.

At a glance

Status

Active not recruiting

Sponsor

Universität des Saarlandes

Enrolment target

Start

01 May 2023

Estimated completion

31 Dec 2025

Acute Decompensated Heart Failure

What is this study about?

When someone has heart failure, their heart isn't pumping blood around their body as well as it should. Sometimes, this condition can suddenly get much worse, and this is called 'acutely decompensated heart failure'. People often need to go to the hospital during these times. Doctors use various medicines to help manage heart failure, and two important types are beta-blockers, like bisoprolol, and a newer group of drugs called SGLT2 inhibitors, such as dapagliflozin and empagliflozin.

At the moment, we don't fully understand how these specific medications work in the body when someone's heart failure has suddenly worsened. For example, how quickly are they absorbed? How long do they stay in the body? And what are their immediate effects? We know that for beta-blockers, it's generally advised to keep taking them if you're already on them and not too unwell. For SGLT2 inhibitors, we think they are safe and helpful even when heart failure is worse, but we need more information.

This study aims to fill these gaps in our knowledge. By looking closely at how bisoprolol and SGLT2 inhibitors behave in people with acutely decompensated heart failure, we hope to get a clearer picture of their effects and safety. The information gathered could help doctors decide on the best way to use these medications, ensuring patients receive the right treatment at the right dose, making their care even better during these critical periods.

Key takeaways

This study is for adults whose heart failure has recently gotten worse.
It aims to understand how existing heart medicines (bisoprolol and SGLT2 inhibitors) work during this time.
The findings could help doctors improve how they treat heart failure patients.
You must already be on a beta-blocker to be considered.
Participation involves extra monitoring while in hospital.

Who may be eligible?

To join this study, people need to be adults aged 18 or over. They must currently be in hospital with heart failure that has suddenly gotten worse. This means they might have symptoms like swollen legs, difficulty breathing because of fluid in their lungs, or a swollen tummy.

Participants should also have been taking a beta-blocker medicine before they came into hospital. Their doctor would have also found that they have high levels of certain blood markers (called natriuretic peptides), which indicate heart strain.

People cannot join the study if they have very severe heart failure where their heart can't pump enough blood (called cardiogenic shock), if they need special machines to help their heart, or if they need medicines to keep their blood pressure up. Other reasons for not being able to join include very low heart rate, very low blood pressure, kidney dialysis, certain gut conditions, or not being able to give their written permission 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 18 years old or older?
Are you currently in hospital because your heart failure has suddenly become worse?
Do you have symptoms like swollen legs, breathing difficulties from fluid, or a swollen tummy?
Were you taking a beta-blocker medicine, like bisoprolol, before coming into hospital?
Are you NOT needing machines or strong medicines to support your heart or blood pressure?

Answer every question to see your result.

What does participation involve?

The detailed involvement isn't fully described in the summary. However, generally, taking part in a study like this might involve a number of things. You would likely have regular blood tests to see how the medications are working in your body and how they're being processed. You might also have regular checks of your heart and overall health while in hospital. The study would focus on how bisoprolol and SGLT2 inhibitors (dapagliflozin or empagliflozin) affect you. The total duration of your participation would depend on how long you are in the hospital for your heart failure. You would continue to receive standard medical care for your condition in addition to the study assessments.

Potential risks and benefits

Potential benefits of taking part could include closer monitoring of your condition and medications, and by contributing to this research, you're helping future patients with similar heart failure. However, there's no guarantee of direct personal benefit from the study. Potential risks are generally low, as the study focuses on medicines you might already be taking or would be prescribed for your condition. Any blood tests or additional monitoring needed for the study could carry minor discomfort or very small risks. You would have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Department of Internal Medicine III, Cardiology, Angiology and Intensive Care Medicine, University Hospital Saarland, Saarland University
Verified postcode
Homburg, Germany

Common questions

What is 'heart failure'?

Heart failure means your heart isn't pumping blood around your body as well as it should. It doesn't mean your heart has stopped working.

What does 'acutely decompensated' mean?

It means your heart failure has suddenly worsened, and you might have more severe symptoms like shortness of breath or swelling.

What are SGLT2 inhibitors?

These are a type of medicine, like dapagliflozin or empagliflozin, that help manage heart failure and other conditions. They were originally used for diabetes.

Will I get a new medicine if I join?

The study looks at medicines you would typically be taking for heart failure, such as bisoprolol or SGLT2 inhibitors. It’s about understanding how they work during a specific time.

Is this a new treatment?

No, this study is looking at existing, approved treatments for heart failure, but in a specific situation where the heart failure has recently gotten worse.