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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

8 criteria

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 trial?

10 criteria

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.

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Verified sites

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Fakultni Nemocnice U Sv Anny V Brne
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Brno-Stred, Czechia
Region Midtjylland
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Aarhus, Denmark
Region Vaesterbotten
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Umea, Sweden

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Investigated drugs

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.

Dapagliflozin

What is already known about the treatment

Dapagliflozin – Dapagliflozin is a medication taken orally, usually in the form of a tablet. It is currently being studied for its potential benefits in reducing the risk of atrial fibrillation and kidney injury after coronary artery bypass surgery. The main therapeutic use of dapagliflozin is to help manage blood sugar levels in people with type 2 diabetes, but it is being explored for other uses in heart and kidney health. At the molecular level, dapagliflozin works by blocking a protein in the kidneys called SGLT2, which helps remove excess sugar from the body through urine. It belongs to a class of drugs known as SGLT2 inhibitors.

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.