Study on Dapagliflozin for Reducing Atrial Fibrillation and Kidney Injury in Patients Awaiting Coronary Artery Bypass Surgery

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What is this study about?

This clinical trial is focused on patients who are waiting to undergo coronary artery bypass surgery, a procedure to improve blood flow to the heart. The study is investigating the use of a medication called dapagliflozin, which is a type of drug known as an SGLT2 inhibitor. The main goal is to see if dapagliflozin can help reduce the risk of developing new onset atrial fibrillation, a type of irregular heartbeat, and acute kidney injury after the surgery.

Participants in the study will be given either dapagliflozin or a placebo, which looks like the real medication but does not contain any active ingredients. The study will take place over a period of time, starting before the surgery and continuing through the hospital stay. Researchers will monitor the participants for any signs of atrial fibrillation or kidney injury, as well as other health outcomes such as heart failure, stroke, and overall safety of the medication.

The study aims to provide valuable information on whether dapagliflozin can be an effective treatment to improve recovery and reduce complications after coronary artery bypass surgery. Participants will be closely observed during their hospital stay and for a period after discharge to ensure their safety and to gather comprehensive data on the effects of the treatment.

1 joining the trial

Upon joining the trial, you will be required to provide your written consent to participate. This confirms your understanding and agreement to be part of the study.

You must be at least 18 years old and scheduled for coronary artery bypass grafting (CABG) surgery, possibly with additional procedures like valve replacement or repair.

2 medication administration

You will be randomly assigned to receive either the active medication, dapagliflozin, or a placebo. The medication is in the form of a 10 mg film-coated tablet.

The tablet is taken orally once a day. The duration of administration will be during your hospital stay following the CABG surgery.

3 monitoring during hospitalization

During your hospital stay, your heart rhythm will be monitored to detect any new onset of atrial fibrillation (AF), which is a type of irregular heartbeat.

Your kidney function will also be monitored to check for any signs of acute kidney injury (AKI). This involves measuring changes in your blood creatinine levels and urine output.

4 safety and tolerability assessment

Throughout the trial, any side effects or adverse events will be recorded. This includes any serious adverse events (SAEs) or unexpected side effects related to the medication.

The safety and tolerability of dapagliflozin will be assessed from the start of treatment until one week after you are discharged from the hospital.

5 follow-up assessments

After your discharge, follow-up assessments will be conducted to monitor your health status. This includes checking for any new heart-related issues, such as heart failure or stroke.

Your overall health and any hospital readmissions will be tracked for up to 12 months after your surgery.

Who Can Join the Study?

The patient must have given their written consent to participate in the study.
The patient must be at least 18 years old at the time of giving written consent.
The patient must have a condition called chronic coronary syndrome, which is a long-term heart condition. This must be confirmed by a test called coronary angiography, which looks at the blood vessels of the heart.
The patient must be scheduled for a type of heart surgery called coronary artery bypass grafting (CABG) with the use of a machine that helps circulate blood during the surgery, known as extra corporeal circulation.
The patient may also be scheduled for additional heart procedures during the CABG surgery, such as:
- Aortic valve replacement – replacing a valve in the heart.
- Mitral valve replacement or repair – replacing or fixing another valve in the heart.
- Aortic root surgery – surgery on the part of the heart where the aorta begins.
Both male and female patients can participate in the study.

Who Cannot Join the Study?

Patients who have had a recent heart attack.
Patients with severe liver disease.
Patients with a history of severe allergic reactions to medications.
Patients who are currently participating in another clinical trial.
Patients with uncontrolled high blood pressure.
Patients with severe kidney disease.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients with certain types of cancer.
Patients with a history of certain heart rhythm problems.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Region Oerebro Laen	Orebro	Sweden
Region Vaesterbotten	Umea	Sweden
Region Oestergoetland	Linkoping	Sweden
Odense University Hospital	Odense	Denmark
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	01.02.2024
Denmark	Recruiting	01.02.2024
Sweden	Recruiting	01.02.2024

Trial locations

Investigated drugs:

Dapagliflozin

Dapagliflozin is a medication used in this clinical trial. It belongs to a group of drugs called SGLT2 inhibitors. These medications help lower blood sugar levels in people with type 2 diabetes by helping the kidneys remove sugar from the body through urine. In this trial, dapagliflozin is being tested to see if it can reduce the risk of developing a heart rhythm problem called atrial fibrillation and kidney injury after heart surgery. The goal is to see if taking dapagliflozin can help patients recover better after their surgery.

Investigated diseases:

Atrial Fibrillation – Atrial fibrillation is a heart condition characterized by an irregular and often rapid heart rate. It occurs when the upper chambers of the heart (atria) beat out of sync with the lower chambers (ventricles). This can lead to poor blood flow and symptoms such as heart palpitations, shortness of breath, and fatigue. The condition can develop suddenly and may be triggered by stress, illness, or surgery. Over time, atrial fibrillation can become persistent or permanent if not managed. It can also increase the risk of stroke and other heart-related complications.

Acute Kidney Injury – Acute kidney injury is a sudden episode of kidney failure or kidney damage that happens within a few hours or days. It causes a build-up of waste products in the blood and makes it hard for the kidneys to maintain the right balance of fluid in the body. This condition can occur due to a variety of factors, including reduced blood flow to the kidneys, direct damage to the kidneys, or blockage of the urinary tract. Symptoms may include decreased urine output, swelling due to fluid retention, and fatigue. Acute kidney injury can progress rapidly, leading to serious health issues if not addressed. It is often reversible with prompt treatment and care.

Trial ID:

2023-505375-75-00

Protocol code:

STENOTYPE-2023

NCT ID:

NCT05852704

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Dapagliflozin for Reducing Atrial Fibrillation and Kidney Injury in Patients Awaiting Coronary Artery Bypass Surgery

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?