The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
Congestive Heart Failure
About this trial
This is an interventional treatment trial for Congestive Heart Failure focused on measuring Left Ventricular Assist Device Implantation, Progressive Left Ventricular Failure
Eligibility Criteria
Inclusion criteria: Scheduled to undergo their first LVAD implantation, (or at least 6 months after explanation of a previous LVAD). Has a pulmonary vascular resistance of at least 2.5 Wood units (200 dynes/sec.) in the 30 days prior to LVAD placement. Greater than 18 years of age. Signed IRB approved informed consent. 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.
Sites / Locations
- Newark Beth Isreal Medical Center
- Duke University Medical Center
- University of Cincinnati
- Cleveland Clinic Foundation
- Allegheny General Hospital
- Baylor University Medical Center
- University of Texas/St. Paul Medical Center
- Texas Heart Institute
- Herz-und Diabeteszentrum Nordrhein-Westfalen
- Deutsches Herfzzentrum Berlin
- Harefield Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Inhaled Nitric Oxide
Nitrogen
Inhaled Nitric Oxide (iNO) at 40 parts per million (ppm)
Nitrogen (N2) administered at 40 ppm.