At a glance
ClinicalIndex Comparison Record- ✓Scheduled to undergo first LVAD implantation, or at least 6 months after explanation of previous LVAD
- ✓Pulmonary vascular resistance ≥2.5 Wood units (200 dynes/sec) within 30 days prior to LVAD placement
- ✓Age >18 years
- ✕Congestive heart failure due to giant cell myocarditis or restrictive cardiomyopathy
- ✕Elective BiVAD surgery or current temporary BiVAD support
- ✕LVAD procedure expected without cardiopulmonary bypass
- ✕Pregnancy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assist Device (LVAD) Implantation
In Brief
A Phase 2 clinical trial evaluating Nitric Oxide and Nitrogen for Congestive Heart Failure. Completed, enrolled 150 participants across 11 sites in 3 countries.
Detailed Summary
The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following: * Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m\^2 * Administration of ≥ 20 inotropic equivalents (IE) * 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE * 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE * 1 µg/kg/min milrinone is equivalent to 15 IE * 0.1 U/min vasopressin is equivalent to 10 IE * Mean arterial pressure (MAP) ≤ 55 mmHg * Central venous pressure (CVP) ≥ 16 mmHg * Percent mixed venous oxygen saturation (SvO2) ≤ 55% Or at least one of the following criteria: * Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean' * Death
Study Details
Timeline
Interventions
40 ppm of Nitric Oxide continuously administered for 48 hours
Nitrogen (N2) administered at 40 ppm for 48 hours