The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
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ClinicalTrials.gov Identifier: NCT00060840 |
Recruitment Status :
Completed
First Posted : May 15, 2003
Results First Posted : September 17, 2010
Last Update Posted : August 22, 2016
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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
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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
Condition or disease | Intervention/treatment | Phase |
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Congestive Heart Failure | Drug: Nitric Oxide Drug: Nitrogen | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | The Effects of Nitric Oxide for Inhalation During Left Ventricular Assist Device (LVAD) Implantation |
Study Start Date : | July 2003 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | July 2008 |

Arm | Intervention/treatment |
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Active Comparator: Inhaled Nitric Oxide
Inhaled Nitric Oxide (iNO) at 40 parts per million (ppm)
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Drug: Nitric Oxide
40 ppm of Nitric Oxide continuously administered for 48 hours
Other Name: INOmax |
Placebo Comparator: Nitrogen
Nitrogen (N2) administered at 40 ppm.
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Drug: Nitrogen
Nitrogen (N2) administered at 40 ppm for 48 hours |
- 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 ]
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060840
United States, New Jersey | |
Newark Beth Isreal Medical Center | |
Newark, New Jersey, United States, 07112 | |
United States, North Carolina | |
Duke University Medical Center | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
University of Cincinnati | |
Cincinnati, Ohio, United States, 45219 | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
United States, Pennsylvania | |
Allegheny General Hospital | |
Pittsburgh, Pennsylvania, United States, 15212 | |
United States, Texas | |
Baylor University Medical Center | |
Dallas, Texas, United States, 75226 | |
University of Texas/St. Paul Medical Center | |
Dallas, Texas, United States, 75390 | |
Texas Heart Institute | |
Houston, Texas, United States, 20345 | |
Germany | |
Herz-und Diabeteszentrum Nordrhein-Westfalen | |
Gergstrab, Bad Oeynhausen, Germany, 32545 | |
Deutsches Herfzzentrum Berlin | |
Augustenburger Platz, Berlin, Germany, 13353 | |
United Kingdom | |
Harefield Hospital | |
Harefield, Middlesex, United Kingdom, UB96JH |
Study Director: | James Baldassarre, MD | Mallinckrodt |
Responsible Party: | Mallinckrodt |
ClinicalTrials.gov Identifier: | NCT00060840 |
Other Study ID Numbers: |
INOT 41 |
First Posted: | May 15, 2003 Key Record Dates |
Results First Posted: | September 17, 2010 |
Last Update Posted: | August 22, 2016 |
Last Verified: | July 2016 |
Left Ventricular Assist Device Implantation Progressive Left Ventricular Failure |
Heart Failure Heart Diseases Cardiovascular Diseases Nitric Oxide Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents |
Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Endothelium-Dependent Relaxing Factors Vasodilator Agents Gasotransmitters Protective Agents |