NCT05267886 CAPITAL DOREMI 2: Inotrope Versus Placebo Therapy for Cardiogenic Shock
| NCT ID | NCT05267886 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Ottawa Heart Institute Research Corporation |
| Condition | Shock, Cardiogenic |
| Study Type | INTERVENTIONAL |
| Enrollment | 346 participants |
| Start Date | 2022-03-05 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 346 participants in total. It began in 2022-03-05 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The investigators are interested in determining if there is a meaningful benefit from the use of medications purported to increase the pumping function of the heart (i.e. inotropes) among critically ill patients admitted to the Cardiac Intensive Care Unit (CICU). To do this, the investigators will conduct a multi-centre, double blind, randomized control trial with patients who are deemed to require these medications by their treating physician to one of the two most commonly used agents in Canada (Milrinone or Dobutamine) or placebo. Each patient will be closely monitored by their healthcare team. The dose of medication will be adjusted according to each patients' clinical status. After 12 hours, the participants will move to open label treatment and any continued use of inotropes will be at the discretion of their treating physician.
Eligibility 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
Contact & Investigator
Rebecca Mathew, MD
PRINCIPAL INVESTIGATOR
Ottawa Heart Institute Research Corporation
Frequently Asked Questions
Who can join the NCT05267886 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Shock, Cardiogenic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05267886 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05267886 currently recruiting?
Yes, NCT05267886 is actively recruiting participants. Contact the research team at rmathew@ottawaheart.ca for enrollment information.
Where is the NCT05267886 trial being conducted?
This trial is being conducted at Rochester, United States, Hamilton, Canada, Ottawa, Canada.
Who is sponsoring the NCT05267886 clinical trial?
NCT05267886 is sponsored by Ottawa Heart Institute Research Corporation. The principal investigator is Rebecca Mathew, MD at Ottawa Heart Institute Research Corporation. The trial plans to enroll 346 participants.