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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00060840
First Posted: May 15, 2003
Last Update Posted: August 22, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mallinckrodt
Results First Submitted: August 25, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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 
Other                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 
Overall Participants Analyzed 
[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: Lawrence Hill
Organization: Mallinckrodt
phone: 908-238-6370
e-mail: lawrence.hill@mallinckrodt.com



Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT00060840     History of Changes
Other Study ID Numbers: INOT 41
First Submitted: May 14, 2003
First Posted: May 15, 2003
Results First Submitted: August 25, 2010
Results First Posted: September 17, 2010
Last Update Posted: August 22, 2016