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Study on Dobutamine and Tocilizumab for Patients with Heart Attack at High Risk of Cardiogenic Shock

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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 have experienced an acute myocardial infarction, commonly known as a heart attack, and are at a high risk of developing cardiogenic shock. Cardiogenic shock is a condition where the heart suddenly can't pump enough blood to meet the body's needs. The study is investigating the effects of two treatments: dobutamine and tocilizumab. Dobutamine is a medication that helps the heart pump more effectively, while tocilizumab is a drug that can reduce inflammation in the body. Both medications will be administered through an intravenous infusion, which means they are given directly into a vein.

The purpose of the study is to explore how these treatments might affect certain markers in the blood that indicate heart function and stability. Participants in the study will receive either the medications or a placebo. The study will follow a specific plan where participants will be monitored from the time they are admitted to the hospital until 48 hours after admission. During this time, blood samples will be taken to measure levels of a marker called NTproBNP, which helps assess heart health. Additionally, other tests such as MRI scans and echocardiograms, which are imaging techniques to look at the heart, will be conducted to gather more information about heart function and recovery.

The study aims to provide insights into how these treatments might help prevent complications like cardiogenic shock in patients who have had a heart attack. It will also look at other outcomes such as the size of the heart attack, inflammation levels, and overall heart function. The trial is designed to be double-blinded, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, ensuring unbiased results. The study is expected to continue until April 2025.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after meeting specific criteria: experiencing an acute myocardial infarction, undergoing a procedure called PCI, presenting within 24 hours of chest pain, having an ORBI risk score of 11 or higher, and being at least 18 years old.
Step 2
Initial assessment
Upon admission to the hospital, blood samples are taken to measure NTproBNP levels. This helps assess the risk of developing hemodynamic instability or cardiogenic shock.
Step 3
Medication administration
A single dose of Tocilizumab is administered through an intravenous infusion. This medication is a concentrate for solution, given to help manage inflammation.
A low-dose Dobutamine infusion is also administered intravenously. This medication supports heart function and is given as a solution for infusion.
Step 4
Monitoring period
Blood samples are collected up to 48 hours after hospital admission to monitor NTproBNP levels.
Additional assessments include measuring infarct size using cMRI, evaluating biomarkers related to heart function and inflammation, and performing echocardiographic measurements.
Step 5
Follow-up assessments
During the hospital stay, the development of cardiogenic shock, cardiac arrest, or the need for intensive care is monitored.
Long-term outcomes such as mortality, re-admission rates, and quality of life are assessed over the following year.
Step 6
Conclusion of participation
The study is estimated to conclude by April 1, 2025. Participation involves ongoing monitoring and assessments to evaluate the effectiveness and safety of the treatments.

Who can join the trial?

5 criteria

The patient must have had an acute myocardial infarction, which is a heart attack.
The patient must have undergone revascularization with PCI, which is a procedure to open blocked heart arteries.
The patient must have experienced chest pain and sought medical attention within 24 hours of its onset.
The patient must have an ORBI risk score of 11 or higher. This score helps assess the risk of developing a serious heart condition called cardiogenic shock.
The patient must be 18 years or older.

Who cannot join the trial?

8 criteria

Patients who have had a heart attack more than 24 hours ago.
Patients who are already in a state of severe heart failure, known as **cardiogenic shock**, when they arrive at the hospital. **Cardiogenic shock** is a condition where the heart suddenly can't pump enough blood to meet the body's needs.
Patients who are not at an intermediate to high risk of developing **cardiogenic shock**. This risk is assessed using a specific score called the **ORBI risk score**.
Patients who are not within the specified age range for the study.
Patients who are not able to give informed consent or understand the study requirements.
Patients who have other medical conditions that might interfere with the study or its results.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.

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Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

Dobutamine
is a medication used in this trial to help improve heart function. It is given as an infusion, which means it is delivered directly into the bloodstream through a vein. Dobutamine works by helping the heart pump more effectively, which can be important for patients who have had a heart attack and are at risk of developing heart failure or cardiogenic shock.
Tocilizumab
is another medication used in this trial. It is given as a single intravenous dose, meaning it is injected directly into a vein. Tocilizumab is typically used to reduce inflammation in the body. In this study, it is being tested to see if it can help reduce the risk of heart complications after a heart attack by affecting certain proteins in the blood that are linked to inflammation and heart stress.

What is already known about the treatment

Dobutamine
Dobutamine is administered intravenously and is used primarily in hospital settings. It is currently well-documented in medical literature as a treatment for heart conditions, particularly in cases of acute heart failure and cardiogenic shock. The main therapeutic indication for dobutamine is to improve heart function in patients with acute myocardial infarction who are at high risk of developing cardiogenic shock. At the molecular level, dobutamine works by stimulating beta-1 adrenergic receptors in the heart, which increases heart rate and strength of contraction, thereby improving blood flow. It is classified as a sympathomimetic drug.
Tocilizumab
Tocilizumab is administered as a single intravenous dose and is typically used in clinical settings. It is recognized in medical literature for its role in treating inflammatory conditions, such as rheumatoid arthritis. In the context of acute myocardial infarction with a high risk of cardiogenic shock, tocilizumab is being studied for its potential to reduce inflammation and improve heart function. The mechanism of action involves blocking the interleukin-6 (IL-6) receptor, which helps reduce inflammation and may stabilize heart function. Tocilizumab is classified as an immunosuppressive drug.

Investigated diseases

Acute Myocardial Infarction with increased risk of Cardiogenic Shock – This condition occurs when blood flow to a part of the heart is blocked for a long enough time that part of the heart muscle is damaged or dies. It is commonly known as a heart attack. In cases with an increased risk of cardiogenic shock, the heart's ability to pump blood is severely compromised, leading to inadequate circulation to the body's organs. This can result in symptoms such as chest pain, shortness of breath, and fatigue. The risk of cardiogenic shock is assessed using specific scoring systems, and it can develop rapidly, requiring immediate medical attention. The progression of this condition can lead to further complications if not managed promptly.