Nebulized Inhaled Milrinone in a Hospitalized Advanced Heart Failure Population

• Status: Recruiting
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Patients with end stage heart failure have significant symptoms (including fatigue and shortness of breath) which prevent them from being able to perform most activities of daily living. Milrinone is one of the inotropic medications that has been studied and used in the treatment of end stage heart failure. End stage heart failure patients awaiting a heart transplantation often have to be maintained on IV milrinone 24 hours a day through a chronic IV line. Two problems arise with this therapy. First, the IV line itself creates an opportunity for infection and blood clots, in addition to interfering with patient's quality of life. Second, patients may be exposed to higher levels of milrinone when given IV than are necessary for maintaining their heart's function.

By doing this study the investigators hope to learn if a new way of giving HF patients milrinone can lower the levels of plasma milrinone which may lessen the chance of medication side effects, while still preserving the beneficial effects of milrinone. Additionally if the inhaled route of administration is effective patients may not need to have invasive IV lines to administer the medication (currently standard practice) which can cause other unwanted side effects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Kansas Medical Center; Vanderbilt University
• Collaborators: Lipscomb University; Vanderbilt University Medical Center
• Treatments: Milrinone

Criteria

Inclusion Criteria:

1. Patients age > 18 years old

2. Symptomatic Stage D heart failure requiring initiation of inotropic medication at the discretion of their cardiologist

3. Signed informed consent

Exclusion Criteria:

1. Patients incapable of signing informed consent for any reason

2. Patients who are pregnant or breastfeeding

3. Systolic blood pressure less than 85 mmHg prior to randomization

4. Documented allergy or adverse reaction to milrinone