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Clinical Trials/EUCTR2005-000326-24-DE
EUCTR2005-000326-24-DE
Active, not recruiting
Not Applicable

The Effects of Nitric Oxide for Inhalation during Left Ventricular Assist Device (LVAD)Implantation. - INOT41

INO Therapeutics0 sites110 target enrollmentJuly 6, 2005
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Conditionsacute right ventricular failureMedDRA version: 9.1Level: LLTClassification code 10063082Term: Acute right ventricular failure
DrugsINOmax for inhalation (800 ppm)

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
acute right ventricular failure
Sponsor
INO Therapeutics
Enrollment
110
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 6, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
INO Therapeutics

Eligibility Criteria

Inclusion Criteria

  • •\-scheduled to undergo their first LVAD implantation, (or at least 6 months after explantation of a previous LVAD).
  • •\- has a pulmonary vascular resistance of at least 2\.5 Wood units (200 dynes/second) in the 30 days prior to LVAD placement.
  • •\- greater than 18 years of age.
  • •\- signed IRB approved informed consent.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range

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.

Outcomes

Primary Outcomes

Not specified

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The Effects of Nitric Oxide for Inhalation during Left Ventricular Assist Device (LVAD) Implantation. - INOT41
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