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

This study has been completed.
Sponsor:
Information provided by:
INO Therapeutics
ClinicalTrials.gov Identifier:
NCT00060840
First received: May 14, 2003
Last updated: September 17, 2010
Last verified: September 2010

May 14, 2003
September 17, 2010
July 2003
June 2008   (final data collection date for primary outcome measure)
The Number of Subjects With Left Ventricular Failure During Left Ventricular Assistance Device (LVAD) Placement After Cardio Pulmonary Bypass, as Determined by Failure Criteria, After Administration of Nitric Oxide. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Failure criteria used to measure outcome includes:

  • Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2
  • Administration of ≥ 20 inotropic equivalents (IE)
  • Mean arterial pressure (MAP) ≤ 55 mm Hg
  • Central venous pressure (CVP) ≥ 16 mm Hg
  • Percentage of mixed venous oxygen saturation (SvO2) of ≤ 55% OR failure to wean from cardio pulmonary bypass (CPB) at least once due to hemodynamic failure or death.
Not Provided
Complete list of historical versions of study NCT00060840 on ClinicalTrials.gov Archive Site
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The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assist Device (LVAD) Implantation

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

40 ppm of either nitric oxide for inhalation or N2 (placebo) will be continuously administered to the patient starting at least 5 minutes prior to initiating the first weaning attempt from CPB and continue until the patient is either extubated, has reached failure criteria, or has been treated with study drug for 48 hours following discontinuation of CPB, whichever come first.

All patients will be monitored peri-operatively with a pulmonary arterial line, central venous line, and systemic arterial line. Baseline data collection by a designated clinical staff member will begin following induction of anesthesia and prior to skin incision. Following a successful wean from cardiopulmonary bypass, post-op data will be collected within 1 hour following end time of surgery. Data will then be collected at 6, 12, 18, 24, and 48 hours from post-op or until extubation, in which case weaning from study drug will begin.

Open label investigational nitric oxide for inhalation may be administered once a patient meets a minimum of two of the failure criteria or fails to wean at least once due to hemodynamic failure from cardiopulmonary bypass.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Congestive Heart Failure
  • Drug: Nitric Oxide
    40 ppm of Nitric Oxide continuously administered for 48 hours
    Other Name: INOmax
  • Drug: Nitrogen
    Nitrogen (N2) administered at 40 ppm for 48 hours
    Other Name: Nitrogen
  • Active Comparator: Inhaled Nitric Oxide
    Inhaled Nitric Oxide (iNO) at 40 parts per million (ppm)
    Intervention: Drug: Nitric Oxide
  • Placebo Comparator: Nitrogen
    Nitrogen (N2) administered at 40 ppm.
    Intervention: Drug: Nitrogen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
July 2008
June 2008   (final data collection date for primary outcome measure)

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany,   United Kingdom
 
NCT00060840
INOT 41
Yes
Rob Small, INO Therapeutics
INO Therapeutics
Not Provided
Study Director: James Baldassarre, MD INO Therapeutics
INO Therapeutics
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP