Ongoing, recruitingTherapeutic use (Phase IV)Interventional

proMoting Effective Renoprotection in Cardiac sURgery patients by Inhibition of SGLT-2

This study, called 'proMote Effective Renoprotection in Cardiac sURgery patients by Inhibition of SGLT-2', is investigating if a drug named Forxiga, taken as a 10mg tablet, can help prevent kidney injury (AKI) in patients undergoing heart surgery. AKI is a sudden decrease in kidney function. This phase IV study means the drug is already approved for other conditions, and researchers are now looking at its effectiveness and safety in a new group of patients. The main goal is to see how many patients experience kidney problems within seven days after surgery when taking Forxiga, compared to those who don't. Researchers will also look at other important health outcomes like hospital stay and overall recovery.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Stichting Amsterdam UMC

Enrolment target

784

Start

25 Jun 2024

AKI

What is this study about?

Heart surgery is a major operation, and sometimes, a complication called Acute Kidney Injury, or AKI, can happen afterwards. AKI means your kidneys suddenly stop working as well as they should. This study is looking into whether a medication called Forxiga could help protect your kidneys during and after heart surgery, potentially reducing the risk of AKI.

Forxiga is a medicine that's already used for other health conditions, like diabetes and heart failure. Researchers are now testing it in this study to see if it can also be helpful for kidney protection in a specific group of people – those having heart surgery. This type of study, called a Phase IV trial, aims to gather more information on how the drug works and its safety when used in a new way or group of patients.

The main thing the researchers want to find out is how often AKI occurs within seven days after heart surgery in patients who receive Forxiga. They will also be looking at many other important things, such as how long people stay in intensive care or hospital, their overall recovery, and other heart-related events. This will help them understand the full picture of how Forxiga might affect patients undergoing heart surgery.

Key takeaways

This study investigates if Forxiga can protect kidneys during heart surgery.
It aims to reduce the risk of kidney problems (AKI) after the operation.
Forxiga is already approved for other conditions like diabetes.
The study will track kidney function, hospital stay, and overall recovery.
Open to adults aged 18 and over, both men and women.
Taking part is voluntary and you can withdraw at any time.

Who may be eligible?

This study is looking for adults who are aged 18 years and older, with no upper age limit. Both men and women are welcome to take part.

The research team will need to check your medical history to make sure that taking part in this study is suitable and safe for you. This means they will look at your current health conditions and any other medicines you are taking to ensure the study drug, Forxiga, is appropriate for you.

It's important to have a full discussion with the study team to understand if you meet all the necessary requirements to participate. They will explain everything clearly and answer any questions you might have.

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 scheduled to have heart surgery?
Are you able to take 10mg tablets?
Are you comfortable filling out questionnaires about your health and recovery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, Forxiga 10mg tablets. This medicine would be taken around the time of your heart surgery. The study team would carefully monitor your health and recovery while you are in hospital.

After your surgery, the research team would closely track how your kidneys are functioning for about seven days. They would also monitor other aspects of your health, such as how long you stay in intensive care and in the hospital overall. You might also be asked to fill out some questionnaires about your recovery and quality of life at different points.

Throughout the study, regular checks would be carried out, including monitoring your blood sugar levels and vital signs. The study team would also be looking out for any side effects from the medication. The total time you'd be involved in the study would depend on your recovery, but the main follow-up for kidney function is within seven days after surgery, with broader health assessments continuing for some time.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as contributing to medical knowledge that might help future patients undergoing heart surgery. There's also a chance that Forxiga, the study drug, could help protect your kidneys during your recovery. However, like all medications, Forxiga can have side effects, which might include kidney problems, infections, or issues with blood sugar levels. The study team will monitor you closely for any of these. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is AKI?

AKI stands for Acute Kidney Injury. It means your kidneys suddenly stop working as well as they should, which can happen after major surgery.

What is Forxiga?

Forxiga is a medicine, given as a 10mg tablet, which is currently used for conditions like diabetes and heart failure. This study is looking at if it can also help protect kidneys during heart surgery.

What is a Phase IV trial?

A Phase IV trial means the medicine is already approved for some health conditions, and researchers are studying it further to see how it works in new situations or groups of patients, and to gather more safety information.

Will I know if I'm getting Forxiga or not?

In many studies like this, patients don't know if they are getting the study drug or a placebo (a dummy pill) to ensure the results are unbiased. The study team can give you more details about this specific trial design.

What does 'LoS-ICU' mean?

LoS-ICU stands for 'Length of Stay in the Intensive Care Unit.' It refers to how many days a patient spends in intensive care.