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

History of Changes

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
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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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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 ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: No text entered.

Limitations and Caveats

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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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

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