AuthorisedTherapeutic use (Phase IV)Interventional

Acetazolamide in combination with SGLT2i in patients with volume overload and acute heart failure

This study is testing a new way to help people who have acute heart failure. This is when your heart suddenly can't pump enough blood around your body, leading to a build-up of fluid. Sometimes this is called 'volume overload'. The study combines two already approved heart medications, Jardiance and Forxiga, with another medicine called Diamox. Researchers want to see if using these medicines together helps the body get rid of more salt and excess water. Getting rid of this extra salt and water is important because it can reduce swelling and make it easier for your heart to work. This is a Phase IV study, meaning the drugs are already approved, but researchers are looking for new ways to use them to improve treatment.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Ziekenhuis Oost Limburg

Enrolment target

Start

15 Jan 2025

Acute Heart Failure

What is this study about?

When someone has acute heart failure, your heart suddenly struggles to pump blood effectively, which can lead to extra fluid building up in the body. This build-up, called 'volume overload', can cause symptoms like breathlessness and swelling, and it makes your heart work even harder. Doctors often give medicines to help the body get rid of this extra fluid, usually by making you pass more urine.

This study is looking at a new combination of medicines to help manage this fluid build-up. It combines two medications that are already used for heart conditions, called Jardiance and Forxiga, with another drug called Diamox. The main goal is to see if using these three medicines together helps people get rid of more salt through their urine over 24 hours. Getting rid of more salt often means getting rid of more water too, which can ease some of the strain on the heart.

Researchers will also look at how much extra fluid leaves the body in a day, changes in weight, and how much swelling and congestion (fluid in the lungs) improves. They'll also check other things like how the heart looks using special scans, and changes in certain body chemicals, to get a full picture of how this new treatment approach works.

Key takeaways

Study tests a new combination of existing medicines for acute heart failure.
Aims to help the body get rid of excess salt and water more effectively.
Involves collecting urine samples and regular checks of fluid levels and weight.
Open to adults aged 18 and over who have acute heart failure.
This is a Phase IV trial, looking at new ways to use approved drugs.

Who may be eligible?

To take part in this study, you need to be an adult, aged 18 years or older. The study is open to both men and women.

Since the study is about acute heart failure and fluid build-up, you would need to have been diagnosed with this condition.

Researchers will perform checks to make sure the study treatment is safe and suitable for each person. They will look at your overall health and any other medications you might be taking to ensure you meet all the necessary requirements.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with acute heart failure?
Are you willing to take the study medications?
Are you able to provide urine samples over 24 hours?
Are you comfortable with regular medical check-ups and scans?

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, you would receive the study medications: Jardiance 10 mg tablets, Forxiga 10 mg tablets, and an injection of Diamox 500 mg. Over a 24-hour period, a key part of the study involves collecting your urine to measure how much salt you pass. You will also have your blood taken to check different levels, and your weight will be measured regularly. Doctors will perform checks to assess any swelling or fluid build-up using special methods like ultrasound scans of your heart, lungs, and tummy to see how fluid levels are changing. The total duration of your participation in the study would be explained in full by the study team, including how many visits are needed and what each visit involves.

Potential risks and benefits

Potential benefits of taking part could include receiving a new combination therapy that might improve how your body gets rid of excess fluid, potentially easing heart failure symptoms. However, as with any medication, there are potential risks and side effects, which doctors will explain fully. These might include changes in blood pressure, kidney function, or electrolyte levels. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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Belgium

Common questions

What is 'acute heart failure'?

Acute heart failure means your heart suddenly can't pump enough blood around your body, leading to quick build-up of fluid, often causing breathlessness and swelling.

What do the medicines do?

Jardiance, Forxiga, and Diamox are used together to help your body get rid of extra salt and water, which can ease the strain on your heart caused by fluid build-up.

Will I have to stay in hospital?

The study does not specify if you will need to stay in hospital. The study team will explain all the details of your participation, including where and when visits will happen.

What is measured during the study?

Doctors will measure how much salt leaves your body in your urine over 24 hours, how much fluid you pass, your weight, and check for swelling and fluid build-up using scans.

Is this a new medicine?

No, all three medicines (Jardiance, Forxiga, Diamox) are already approved. This study is testing if using them together is a better way to treat acute heart failure than current methods.