Comparing heart medications for patients in cardiogenic shock
Official title: CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock
Run by Ottawa Heart Institute Research Corporation · NCT05267886 · Data updated 2026-11-12
This study tests whether two heart medications, Dobutamine and Milrinone, can help critically ill patients in cardiogenic shock feel better compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 346 (estimated) |
| Sponsor | Ottawa Heart Institute Research Corporation Academic / other |
| Locations | 3 sites (Rochester, Minnesota and 2 other locations) |
| Status | Recruiting |
| Started | March 5, 2022 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT05267886 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients aged 18 and older who are admitted to an intensive care unit with SCAI class C or D cardiogenic shock.
✕Probably not a fit
Patients who are pregnant, have severe valvular lesions, or have recently received inotropes may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effectiveness of inotropes, specifically Dobutamine and Milrinone, compared to a placebo in critically ill patients experiencing cardiogenic shock. Conducted as a multi-centre, double-blind, randomized control trial, it aims to determine if these medications can improve heart function and patient outcomes. Participants will be closely monitored, and medication dosages will be adjusted based on their clinical status. After 12 hours, treatment will transition to open label, allowing physicians to decide on continued inotrope use.
Why it matters
Potential benefit: If successful, this study could provide evidence for the safe and effective use of inotropes in treating cardiogenic shock, potentially improving patient survival and recovery.
How similar studies have gone: Previous studies have shown mixed results regarding the use of inotropes in cardiogenic shock, indicating that while some evidence exists for their use, the certainty of benefit remains low.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients ≥ 18 years of age admitted to an intensive care unit * SCAI class C or D cardiogenic shock Exclusion Criteria: * Unwilling or unable to obtain informed consent by the participant or substitute decision maker * Patients who are currently pregnant or breast-feeding * Patients presenting with an out-of-hospital cardiac arrest (OHCA) * Administration of milrinone or dobutamine in the 24 hours preceding anticipated randomization * Severe obstructive valvular lesions, including aortic stenosis and/or mitral stenosis * Dynamic left ventricular outflow tract obstruction
Where it's running
-
Hamilton Health Sciences
Hamilton, Ontario, Canada Recruiting -
University of Ottawa Heart Institute
Ottawa, Ontario, Canada Recruiting -
Mayo Clinic
Rochester, Minnesota, United States Not yet recruiting
Study contacts
- Principal investigator: Rebecca Mathew, MD — Ottawa Heart Institute Research Corporation
- Study coordinator: Rebecca Mathew, MD
- Email: rmathew@ottawaheart.ca
- Phone: 613-696-7406
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Digital out-of-hospital care for people with early cardiogenic shock
This trial tests whether the HeartMed-HF digital out-of-hospital management program can reduce one-year deaths and unplanned hospital readmissions in adults with early cardiogenic shock.
-
Invobenitug (procizumab) for cardiogenic shock care
This trial will test procizumab (Invobenitug) to see if it is safe and tolerated in adults with cardiogenic shock who need vasopressors and have high cDPP3 levels.
-
Investigating left ventricle unloading during extracorporeal life support
This study looks at how different methods of relieving pressure on the heart can help patients on a special life support system called VA ECLS, especially those in serious heart trouble.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.