RecruitingPHASE4INTERVENTIONAL

CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock

This study, called CAPITAL DOREMI 2, is investigating if certain heart-strengthening medicines, known as inotropes (specifically Dobutamine or Milrinone), really improve outcomes for patients critically ill with cardiogenic shock. Cardiogenic shock is a severe condition where the heart can't pump enough blood to the body. While these medicines are often used, it's not fully clear if they always help or could even cause harm. In this study, patients who need these medicines will be given either one of the actual medicines or a placebo (a dummy treatment). This is done "blind" so neither the patient nor their doctor knows what they're receiving at first. The aim is to find out if these commonly used drugs make a real, positive difference.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Ottawa Heart Institute Research Corporation

Enrolment target

346

Start

05 Mar 2022

Estimated completion

01 Dec 2026

Shock, Cardiogenic

What is this study about?

When someone is in a very serious condition called cardiogenic shock, their heart isn't strong enough to pump blood properly to all parts of their body. This can be life-threatening. Doctors often use medicines called inotropes to try and make the heart pump more effectively. Two common inotropes are Dobutamine and Milrinone.

However, despite their frequent use, we don't fully understand if these medicines always help patients with cardiogenic shock, or if they might sometimes cause other problems. Previous studies have shown mixed results, and there's a suggestion that they could even lead to longer stays in hospital or, in some cases, worse outcomes. This study aims to get a clearer answer by carefully comparing these medicines with a placebo.

Researchers want to see if giving these medicines at the start of treatment genuinely leads to better recovery and fewer complications, or if other approaches might be just as effective or even safer. This will help doctors make the best decisions for patients in the future.

Key takeaways

The study investigates if heart-boosting medicines (inotropes) truly help patients with severe cardiogenic shock.
You might receive one of two active medicines (Dobutamine or Milrinone) or a placebo (dummy treatment).
Neither you nor your doctors will know which treatment you're on at first.
Your medical care will be closely monitored throughout the study.
The study aims to improve future treatment for people with cardiogenic shock.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older and be admitted to an intensive care unit (ICU) because you have cardiogenic shock that your doctors believe needs treatment with inotrope medicines.

However, there are reasons you wouldn't be able to join. For example, if you or your family (who can make medical decisions for you) aren't able to give your informed permission, you couldn't take part. Also, if you are pregnant or breastfeeding, or if you've had a cardiac arrest outside of the hospital, you would not be eligible.

Other reasons you might not be able to join include having already received certain inotrope medicines (Milrinone or Dobutamine) in the 24 hours before the study, or if you have specific serious heart valve problems or another heart condition that blocks blood flow from your heart.

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 currently in an intensive care unit (ICU) for cardiogenic shock?
Are you pregnant or breastfeeding?
Have you recently had a cardiac arrest outside of the hospital?
Do you have certain heart valve problems or blockages?

Answer every question to see your result.

What does participation involve?

If you are eligible and agree to take part, your medical team will decide you need a heart-boosting medicine for your condition. You will then be randomly assigned, like flipping a coin, to receive either Dobutamine, Milrinone, or a placebo (a dummy medicine that looks the same). Neither you nor your doctors will know which treatment you are getting at this stage, which helps ensure the study results are fair.

Your healthcare team will closely monitor you and adjust the dose of the study medicine based on your clinical needs for about 12 hours. After this initial period, your doctors will know which treatment you received. They will then decide if you need to continue with inotrope medicines, and if so, which ones are best for you. There are no extra visits or assessments beyond the medical care you would normally receive in the intensive care unit.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit if the specific medicine you receive improves your heart function and recovery. However, it's also possible that the medicines might have side effects, or that the placebo could be less effective than the active medicine your doctor might normally choose. The study is designed to be very carefully monitored by your medical team to ensure your safety. You are free to withdraw from the study at any time for any reason, without affecting your standard medical care.

Locations (3)

Mayo Clinic
Verified postcode
Rochester, United States· Not yet recruiting
Hamilton Health Sciences
Verified postcode
Hamilton, Canada· Recruiting
University of Ottawa Heart Institute
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is cardiogenic shock?

It's a very serious condition where your heart can't pump enough blood to meet your body's needs, often after a heart attack.

What are inotropes?

These are medicines that help your heart muscle squeeze more strongly, aiming to improve blood flow.

What does 'placebo' mean?

A placebo is a dummy treatment that looks just like the real medicine but contains no active ingredients. It helps researchers fairly compare treatments.

Why don't the doctors know what I'm receiving?

This is called a 'blinded' study. It's done so that neither the patient nor the doctor's knowledge of the treatment can influence the results, making the findings more accurate.

How long will I be on the study medicine?

You will be on the study medicine (Dobutamine, Milrinone, or placebo) for about 12 hours. After that, your doctors will know what you received and will make decisions about your ongoing care.

How to find out more

Rebecca Mathew, MD

rmathew@ottawaheart.ca 613-696-7406 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.