Inhaled milrinone and epoprostenol before heart surgery to ease weaning from bypass

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, controlled study investigates whether pre-emptive inhaled milrinone and epoprostenol improve outcomes for adults undergoing cardiac surgery with cardiopulmonary bypass who have right ventricular dysfunction or pulmonary hypertension. Participants receive the inhaled combination before bypass initiation or a placebo, with the goal of smoother weaning from bypass and better perioperative stability. The trial evaluates hemodynamic parameters, perioperative metrics, and postoperative outcomes to determine potential benefits and safety of the combination therapy. Eligible patients include adults undergoing CPB-assisted cardiac surgery at Montreal Heart Institute; those with certain cardiomyopathies, prior heart transplant or VAD, urgent surgeries, or monitoring contraindications are excluded. The study aims to clarify whether this approach reduces difficult CPB separation and improves recovery.

Why it matters

Who can join: the full rules

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.

Where it's running

• Montreal Heart Institute
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: André Denault, MD, PhD — Montreal Heart Institute
• Study coordinator: Stephanie Jarry, PhD (c)
• Email: stephanie.jarry.1@umontreal.ca
• Phone: 5149289258

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.