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Completed

NCT Number: NCT01571037

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

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

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Key information

Conditions

End Stage Heart Disease Cardiovascular Diseases Heart Diseases Right Ventricular Dysfunction Ventricular Dysfunction Ventricular Dysfunction, Right

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198-2265, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For BTT candidates:
  • Must be an approved candidate for heart transplantation according to institutional policy
  • For DT candidates:
  • Patients with New York Heart Association (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
  • Left ventricular ejection fraction (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 informed consent

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

Treatment and study plan

Inhaled, nebulized, Milrinone

Drug

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.

Other names: Primacor

inhaled nebulized milrinone

Drug

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

Other names: Primacor

Primary outcomes

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

    Time frame: 12 and 24 hours

    • Arrhythmias:
    • Atrial
    • Ventricular
    • 'Sustained' hypotension
    • Hypersensitivity reaction to milrinone

Secondary outcomes

  1. Efficacy - Hemodynamic

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

    Invasive Hemodynamic pulmonary catheter:

    • PAS, PAD, mPAP, RA pressures, PCWP, CI, RVSWi (calculated), TPG, PVR, and SvO2

  2. Efficacy - Echocardiographic

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

    Echocardiographic

    • RV dimensions
    • RV systolic functional assessment
    • Tricuspid valve regurgitation
    • Pulmonary Vascular resistance

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Thoratec Corporation

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 4, 2012
Registry last updated
Sep 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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