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CompletedNCT01571037Updated Sep 6, 2023

Inhaled Milrinone Use in Patients Receiving HeartMate II LVAD: A Pilot Study

A Phase 1 interventional study of Inhaled, nebulized, Milrinone and inhaled nebulized milrinone in End Stage Heart Disease and Right Ventricular Dysfunction, sponsored by University of Nebraska. Completed at 1 site in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by University of Nebraska · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
19 Years and older
Sex
All
01

Study summary

Right ventricular (RV) failure occurs in an estimated 5-41% of cases involving left ventricular assist device (LVAD) implantation and has been shown to adversely affect peri-operative morbidity and mortality. Current therapies to improve RV dysfunction pre and post-operatively are limited. Inhaled milrinone has been shown in several small human studies to be safely tolerated and provide favorable effects on pulmonary hemodynamics.

Study Hypothesis: Delivery of inhaled milrinone, a phosphodiesterase III inhibitor, may provide pulmonary artery vasodilation and therefore improved RV function in patients with end stage heart failure receiving HeartMate II LVAD as a bridge to cardiac transplantation or as destination therapy.

Specifically, we aim to:

  • demonstrate safety of inhaled milrinone in this patient cohort
  • demonstrate efficacy of inhaled milrinone in this patient cohort
Read the detailed description

Right ventricular (RV) failure occurs in an estimated 5-41% of cases involving left ventricular assist device (LVAD) implantation and has been shown to adversely affect peri-operative morbidity and mortality. Current therapies to improve RV dysfunction pre and post-operatively are limited. Inhaled milrinone has been shown in several small human studies to be safely tolerated and provide favorable effects on pulmonary hemodynamics.

Study Hypothesis: Delivery of inhaled milrinone, a phosphodiesterase III inhibitor, may provide pulmonary artery vasodilation and therefore improved RV function in patients with end stage heart failure receiving HeartMate II LVAD as a bridge to cardiac transplantation or as destination therapy.

Specifically, the aims are:

demonstrate safety of inhaled milrinone in this patient cohort demonstrate efficacy of inhaled milrinone in this patient cohort

02

Conditions studied

  • End Stage Heart Disease
  • Right Ventricular Dysfunction

Keywords

  • mechanical circulatory assist device
03

In context

Ventricular Dysfunction, Right

90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.

This study's enrollment of 10 is below the median of 60 across 38 interventional studies indexed under Ventricular Dysfunction, Right.

Browse Ventricular Dysfunction, Right studies →

Lead sponsor

University of Nebraska is the lead sponsor of 496 studies on the registry; 67 are open to participants now.

Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.

Browse University of Nebraska studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. For BTT candidates:

    • Must be an approved candidate for heart transplantation according to institutional policy

  2. For DT candidates:

    • Patients with (NYHA) class IV symptoms that have failed to respond to maximal medical therapy including beta blocker and angiotensin converting enzyme inhibitors if tolerated for at least 45 of 60 days, OR dependence on continuous inotropic therapy for 14 days OR dependence on intra-aortic balloon pump (IABP) for 7 days
    • (LVEF) \< 25%
    • Patients with functional limitations on cardiopulmonary stress testing with a peak oxygen consumption of ≤ 14 ml/kg/min unless balloon pump or inotrope dependent or physically unable to perform the test.
    • Patients not deemed to be a heart transplant candidate after evaluation
    • Must have mean PAP > 25 mmHg by pulmonary catheter indices pre-operatively (within 72 hrs) and/or a PVR > 3 Woods units (WU).
    • Age ≥ 19 years old (in the state of Nebraska, an individual must be ≥ 19 years old to legally provide consent as compared to age ≥ 18 in most other states)
    • Signed

Exclusion criteria

Exclusion Criteria:

  • Age \< 19 years old
  • Pregnancy or current breast feeding
  • Undergoing cardiac transplantation without implantation of mechanical assist device
  • Documented medical allergy to milrinone
  • Failure to meet inclusion criteria for LVAD implantation for BTT or DT indications
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Other
    inhaled nebulized Milrinone

    Drug: Inhaled, nebulized, Milrinone 1 mg/ml milrinone (dissolved in dextrose) and diluted in 0.9% normal saline in a 1:1 ratio to final drug concentration of 0.5mg/ml will be delivered via an IV pump at a fixed dose of 12 ml/hour which will run into a vibrating mesh nebulizer reservoir, connected to the mechanical ventilator circuit. Inhaled milrinone will begin at time of resumption of mechanical ventilation when initiating wean from cardiopulmonary bypass after LVAD implantation in the operating room, and run continuously for a total maximum duration of 24 hours OR until the patient is extubated whichever occurs first. Plasma milrinone levels will be assessed to determine if systemic milrinone absorption occurs after prolonged milrinone inhalation.

    Drug: Inhaled, nebulized, Milrinone · Drug: inhaled nebulized milrinone

Interventions

  • DrugInhaled, nebulized, Milrinone

    1 mg/ml milrinone (dissolved in dextrose) and diluted in 0.9% normal saline in a 1:1 ratio to final drug concentration of 0.5mg/ml will be delivered via an IV pump at a fixed dose of 12 ml/hour which will run into a vibrating mesh nebulizer reservoir, connected to the mechanical ventilator circuit. Inhaled milrinone will begin at time of resumption of mechanical ventilation when initiating wean from cardiopulmonary bypass after LVAD implantation in the operating room, and run continuously for a total maximum duration of 24 hours OR until the patient is extubated whichever occurs first. Plasma milrinone levels will be assessed to determine if systemic milrinone absorption occurs after prolonged milrinone inhalation.

    Also known as: Primacor

  • Druginhaled nebulized milrinone

    0.5 mg/ml inhaled nebulized milrinone deliver at 12 ml/hr continuously until either 24 hours or extubated.

    Also known as: Primacor

06

What researchers measure

Primary outcomes

  1. Safety: Incidence of Arrhythmias, Hypotension and Hypersensitivity Reaction

    1. Arrhythmias: * Atrial * Ventricular 2. 'Sustained' hypotension 3. Hypersensitivity reaction to milrinone

    Time frame: 12 and 24 hours

Secondary outcomes

  1. Efficacy - Hemodynamic

    Invasive Hemodynamic pulmonary catheter: * PAS, PAD, mPAP, RA pressures, PCWP, CI, RVSWi (calculated), TPG, PVR, and SvO2

    Time frame: 30, 60 minutes, then every 4 hours thereafter

  2. Efficacy - Echocardiographic

    Echocardiographic * RV dimensions * RV systolic functional assessment * Tricuspid valve regurgitation * Pulmonary Vascular resistance

    Time frame: Pre-op Echocardiography, intraoperative TEE (before and after inhaled milrinone) and postoperative Echocardiography within 48 hours of milrinone initiation

07

Study locations

1 site
  • University of Nebraska Medical Center
    Omaha, Nebraska 68198-2265, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2012 to primary completion in Feb 2013, 9 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 6, 2011
First posted
Apr 4, 2012
StartActual
Apr 5, 2012
Primary completionActual
Feb 1, 2013
CompletionActual
Feb 21, 2014
Last update
Sep 6, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01571037
Lead sponsor
University of Nebraska
Collaborators
Thoratec Corporation
Responsible party
Sponsor
First posted
Apr 4, 2012
Start date
Apr 5, 2012
Primary completion
Feb 1, 2013
Completion
Feb 21, 2014
Last update
Sep 6, 2023

Study contacts

Nicholas A Haglund, MD
principal investigator · University of Nebraska

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Milrinone

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