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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
Results First Received: August 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Congestive Heart Failure
Interventions: Drug: Nitric Oxide
Drug: Nitrogen

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
There were 8 study medical centers that participated and enrolled subjects; 6 centers in the United States and 2 centers in Germany. There were 150 subjects enrolled in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Inhaled Nitric Oxide Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
Nitrogen Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.

Participant Flow:   Overall Study
    Inhaled Nitric Oxide     Nitrogen  
STARTED     73     77  
COMPLETED     69     68  
NOT COMPLETED     4     9  
Change in surgical plan                 2                 6  
Death                 0                 1  
Withdrawal by Subject                 0                 1  
Subinvestigator unavailable                 0                 1  
Physician Decision                 1                 0  
Unknown                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Inhaled Nitric Oxide Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
Nitrogen Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
Total Total of all reporting groups

Baseline Measures
    Inhaled Nitric Oxide     Nitrogen     Total  
Number of Participants  
[units: participants]
  73     77     150  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     73     77     150  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  57.6  ± 9.75     54.0  ± 11.95     55.8  ± 11.04  
Gender  
[units: participants]
     
Female     9     12     21  
Male     64     65     129  
Region of Enrollment  
[units: participants]
     
United States     38     42     80  
Germany     35     35     70  



  Outcome Measures

1.  Primary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: James Baldassarre, MD
Organization: INO Therapeutics
phone: 908-238-6363
e-mail: james.baldassarre@ikaria.com


No publications provided


Responsible Party: Rob Small, INO Therapeutics
ClinicalTrials.gov Identifier: NCT00060840     History of Changes
Other Study ID Numbers: INOT 41
Study First Received: May 14, 2003
Results First Received: August 25, 2010
Last Updated: September 17, 2010
Health Authority: United States: Food and Drug Administration