NCT05450328 Inhaled Milrinone and Epoprostenol for the Prevention of Difficult Cardiac Pulmonary Bypass Separation
| NCT ID | NCT05450328 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Montreal Heart Institute |
| Condition | Right Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 141 participants |
| Start Date | 2025-12-10 |
| Primary Completion | 2028-05-01 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 141 participants in total. It began in 2025-12-10 with a primary completion date of 2028-05-01.
⚠ 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
In cardiac surgery, the presence of pulmonary hypertension (PH) is a prognostic factor associated with increased mortality and morbidity. In this context, one of the main causes of PH is related to reperfusion ischemia during weaning from extracorporeal circulation (CPB). One of the consequences of PH is right ventricular dysfunction. During weaning from CPB, the development of a right ventricular dysfunction is associated with increased requirements for vasopressor and inotropic agents, duration of mechanical ventilation, prolonged intensive care and hospital stay, and increased mortality compared with patients with left ventricular (LV) dysfunction. The management of patients with PH with or without right ventricular (RV) dysfunction relies on several strategies such as the administration of intravenous and inhaled agents, or mechanical ventricular support. Among those agents, the administration of inotropes or pulmonary vasodilators such as epoprostenol, milrinone and nitric oxide are among the most widely used treatments recommended by the Canadian Cardiovascular Society. At the Montreal Heart Institute, inhaled epoprostenol and milrinone are routinely administered to patients with PH or LV dysfunction in the perioperative setting. Despite the frequent use of inhaled epoprostenol and milrinone, Health Canada has not yet approved the use of these molecules. The primary objective of this multicenter, double-blind, randomized clinical trial is to evaluate the clinical efficacy of the combined administration of inhaled epoprostenol and milrinone in a cardiac surgery setting. This trial will compare the clinical outcome of 71 patients who will receive inhaled epoprostenol and milrinone before the start of bypass surgery to 71 patients who will receive a placebo before the start of the CPB. The primary clinical outcome is the proportion of patients with an "unsuccessful" CPB weaning defined by the use of an inotrope +/- vasopressor agent or the use of mechanical circulatory support or a return to bypass grafting for hemodynamic reasons. This clinical trial will evaluate the clinical efficacy of the combination of inhaled agents in a cardiac surgery setting. Therefore, if the results of this study are positive, the combination of inhaled epoprostenol and milrinone will optimize the management of patients with pulmonary hypertension with or without a right ventricular dysfunction.
Eligibility Criteria
Inclusion Criteria: \- Only patients undergoing cardiac surgery with CPB and aged 18 years and older will be included in this study. Exclusion Criteria: * The presence of congenital cardiomyopathy, which the correction is the primary objective of the proposed surgery. For example, a patient who requires surgery for atrial septal defect closure only would not be eligible for the study. On the other hand, a patient who undergoes this same surgery in addition to a valve replacement, for example, would be eligible to participate in the study. * Heart transplant or ventricular assist device surgery * Urgent surgery including hemodynamic instability requiring vasopressor agents upon arrival in the operating room * A contraindication to transesophageal ultrasound monitoring or the presence of an unstable cervical spine. * Presence of a contraindication related to Epoprostenol or Milrinone administration such as a documented left ventricular or right ventricular outflow tract obstruction, a severe unaddressed aortic stenosis, or a documented allergy to either of these two molecules.
Contact & Investigator
André Denault, MD, PhD
PRINCIPAL INVESTIGATOR
Montreal Heart Institute
Frequently Asked Questions
Who can join the NCT05450328 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Right Heart Failure. 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 NCT05450328 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05450328 currently recruiting?
Yes, NCT05450328 is actively recruiting participants. Contact the research team at stephanie.jarry.1@umontreal.ca for enrollment information.
Where is the NCT05450328 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT05450328 clinical trial?
NCT05450328 is sponsored by Montreal Heart Institute. The principal investigator is André Denault, MD, PhD at Montreal Heart Institute. The trial plans to enroll 141 participants.
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