The purpose of this study is to assess the effects 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, as defined by two or more of the following:

• Left ventricular flow rate index (LVFRI) <= 1.8 L/min/m2
• Administration of >= 1 ug/kg/min epinephrine or norepinephrine
• Mean arterial pressure (MAP) <= 50 mmHg
• Central venous pressure (CVP) >= 20 mmHg
• Mixed venous oxygen saturation (SvO2) <= 55%

Condition	Treatment or Intervention	Phase
Congestive Heart Failure	Drug: INOmax (nitric oxide) for inhalation	Phase II

Further Study Details: 

Expected Total Enrollment:  100

Patients will receive 40 ppm of either nitric oxide for inhalation or placebo continuously starting at least 5 minutes prior to initiating the first attempt from CPB and continue until the patient is either extubated, has reached failure criteria, or has been treated with study gas for 24 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 and prior to exiting the operating room, data will be again collected upon admission to the ICU. Data will then be collected every 6 hours from the point study gas was started until extubation, or until 24 hours of study gas administration, in which case weaning from study gas will begin.

Open label investigational nitric oxide for inhalation may be administered once a patient meets failure criteria or fails to wean two or more times from cardiopulmonary bypass.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria:

• Scheduled to undergo their first elective LVAD implantation.

Exclusion criteria:

• Had elective biventricular assist device (BiVAD) surgery.
• Pregnant.
• Received nitric oxide therapy or other investigational drug within the past 24 hours.

Robert Small      908-238-6605    Robert.Small@inotherapy.com

New Jersey
      Newark Beth Isreal Medical Center, Newark,  New Jersey,  07112,  United States; Not yet recruiting
North Carolina
      Duke University Medical Center, Durham,  North Carolina,  27710,  United States; Not yet recruiting
Ohio
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States; Not yet recruiting
Texas
      St. Paul University Hospital, Dallas,  Texas,  75235,  United States; Recruiting
      Baylor University Medical Center, Dallas,  Texas,  75226,  United States; Recruiting

Study ID Numbers:  INOT 41
Record last reviewed:  February 2005
Last Updated:  February 7, 2005
Record first received:  May 14, 2003
ClinicalTrials.gov Identifier:  NCT00060840
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08