Ongoing, recruitingTherapeutic use (Phase IV)Interventional

LOW-DOSE DOBUTAMINE INFUSION AND SINGLE-DOSE TOCILIZUMAB IN ACUTE MYOCARDIAL INFARCTION PATIENTS WITH HIGH RISK OF CARDIOGENIC SHOCK DEVELOPMENT (DOBERMANN) - A 2X2 MULTIFACTORIAL, DOUBLE-BLINDED, RANDOMIZED, PLACEBO-CONTROLLED TRIAL

The DOBERMANN study is exploring new treatments for people who have had a heart attack and are at a higher risk of developing a severe condition called cardiogenic shock. Cardiogenic shock is when your heart can't pump enough blood to meet your body's needs. This study is testing two medicines, Dobutrex and RoActemra, to see if they can help improve patient outcomes. It's a 'double-blind' study, meaning neither the patients nor their doctors know who is getting the study drugs and who is getting a dummy drug (placebo). Researchers will monitor heart health, inflammation, and other factors to understand how these treatments might work and improve recovery for heart attack patients at risk of this serious complication.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Rigshospitalet

Enrolment target

100

Start

25 Sep 2024

Acute Myocardial Infarction with increased risk of Cardiogenic Shock

What is this study about?

This research study, called DOBERMANN, is designed for people who have recently had a heart attack and are at a higher risk of developing a very serious condition known as cardiogenic shock. After a heart attack, the heart muscle can be damaged, making it harder for the heart to pump blood effectively to the rest of the body. Cardiogenic shock is a severe form of heart failure where the heart suddenly can't pump enough blood, leading to very low blood pressure and not enough oxygen reaching vital organs. This can be life-threatening.

The main goal of the DOBERMANN study is to find out if giving two specific medicines, Dobutrex (which helps strengthen heartbeats) and RoActemra (which reduces inflammation), can help these patients recover better and lower their risk of cardiogenic shock. We want to see if these treatments can improve how well the heart works, reduce inflammation, and ultimately lead to better health outcomes in the short and long term. This is a "Phase IV" study, meaning the medicines being tested are already approved for other uses, but we are looking at them for this specific situation.

To understand if the treatments are working, researchers will look at a number of things. The main thing they will check is a special marker in the blood called NTproBNP within the first 48 hours of being in hospital, which can tell us about heart strain. They will also look at heart damage using special scans, blood tests for inflammation and general organ health, how well the heart is pumping using ultrasound, and the patient's general well-being and risk of other complications like cardiac arrest. Over time, they will also track quality of life, re-admissions, and survival to see the longer-term effects of the treatments.

Key takeaways

Targets heart attack patients at high risk of a serious complication called cardiogenic shock.
Tests two existing medicines (Dobutrex and RoActemra) to see if they can improve recovery.
Participation involves receiving one or both medicines, or a placebo.
Monitoring includes blood tests, heart scans, and tracking overall health.
The study aims to improve treatments for future heart attack patients.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To be part of this study, you would need to be an adult (18 years or older) who has recently experienced a heart attack. You would also need to be identified by your medical team as being at a higher risk of developing cardiogenic shock, that very serious complication we talked about.

The study welcomes both men and women to participate.

There might be other specific health conditions or medications that would mean you couldn't join, but the overall aim is to include people who are most likely to benefit or provide the most useful information for the study.

Quick self-check

Are you 18 years old or older?
Have you recently had a heart attack?
Has your medical team told you that you are at high risk of cardiogenic shock?
Are you happy to have extra blood tests and heart scans?
Are you able to attend follow-up appointments for about a year?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the DOBERMANN study, you would receive either one of the study medications (Dobutrex through a drip, and a single dose of RoActemra also through a drip) or a placebo (a dummy medicine) shortly after your heart attack. This means some people will receive Dobutrex, some RoActemra, some both, and some neither. You and your doctors would not know which treatment you are receiving, which helps ensure the study results are unbiased.

Throughout your hospital stay, you would have regular blood tests to check heart markers and inflammation. You would also have heart scans (like MRI and ultrasound) to monitor your heart's function and any damage. Doctors would keep a close eye on your general health, including any complications and how you are recovering. After you leave the hospital, there will be follow-up appointments, including a check-up around three months later, which might involve another heart MRI. Researchers will also be checking in on your health and quality of life over the first year after your heart attack. The total duration of active participation and follow-up for the study would likely be at least one year.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might not directly benefit from the treatments in this study, as there’s a chance you could receive a placebo, or the treatments might not work for you. However, the information gathered could help future heart attack patients at risk of cardiogenic shock. Possible risks of taking part could include side effects from the study medications (which would be explained in full detail by the study team) or discomfort from tests like blood draws or MRI scans. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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Denmark

Common questions

What is cardiogenic shock?

It's a serious condition after a heart attack where your heart can't pump enough blood to your body.

What are Dobutrex and RoActemra?

These are medicines, already used for other conditions, being tested to see if they can help heart attack patients.

Will I know if I'm getting the real medicine or a dummy pill?

No, this is a 'double-blind' study, so neither you nor your doctors will know, which helps make the results fair.

How long will I be involved in the study?

You'll have tests and monitoring during your hospital stay and then follow-ups for about a year afterwards.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating at any time, and it won't affect your medical care.