The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation

Completed · Phase 2

Conditions studied: Congestive Heart Failure

In brief

The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following: * Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m\^2 * Administration of ≥ 20 inotropic equivalents (IE) * 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE * 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE * 1 µg/kg/min milrinone is equivalent to 15 IE * 0.1 U/min vasopressin is equivalent to 10 IE * Mean arterial pressure (MAP) ≤ 55 mmHg * Central venous pressure (CVP) ≥ 16 mmHg * Percent mixed venous oxygen saturation (SvO2) ≤ 55% Or at least one of the following criteria: * Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean' * Death

Key facts

Study ID

NCT00060840

Run by

Mallinckrodt

People needed

150

Starts

2003-07-01

Expected to finish

2008-07-01

Last updated by the study team

2016-08-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Scheduled to undergo their first LVAD implantation, (or at least 6 months after explanation of a previous LVAD).
• Has a pulmonary vascular resistance of at least 2.5 Wood units (200 dynes/sec.) in the 30 days prior to LVAD placement.
• Greater than 18 years of age.
• Signed IRB approved informed consent.

You may not qualify if…

• Patients with congestive heart failure due to giant cell myocarditis or restrictive cardiomyopathy.
• Elective Biventricular Assist Device (BiVAD) surgery, or current support with a temporary BiVad.
• LVAD procedure expected to be done without cardiopulmonary bypass.
• Pregnancy (a negative pregnancy test must be documented prior to enrollment).
• Received nitric oxide by inhalation therapy within the past 24 hours.
• Investigational drugs that are expected to change systemic or pulmonary vascular resistance are not allowed.

Where it is running

• Newark Beth Isreal Medical Center — Newark, New Jersey, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States
• Baylor University Medical Center — Dallas, Texas, United States
• University of Texas/St. Paul Medical Center — Dallas, Texas, United States
• Texas Heart Institute — Houston, Texas, United States
• Herz-und Diabeteszentrum Nordrhein-Westfalen — Gergstrab, Bad Oeynhausen, Germany
• Deutsches Herfzzentrum Berlin — Augustenburger Platz, State of Berlin, Germany
• Harefield Hospital — Harefield, Middlesex, United Kingdom

Full record on ClinicalTrials.gov

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