Acute right ventricular failure. MedDRA version: 7.0 Level: LLT Classification code 10054933 Term:
Conditions
Interventions
Product Name: INOmax® (Nitric Oxide)
Product Code: N/A
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: nitric oxide
CAS Number:
Sponsors
INO Therapeutics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The expected study population will include patients undergoing left vetricular assist device (LVAD) implantation. 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to assess the utility of nitric oxide for inhalation for the management of acute right ventricular failure during LVAD placement. Left ventricular assist device- LVAD ; Secondary Objective: The secondary study objectives are: - to assess the safety of nitric oxide for inhalation in this patient population. - to assess the effect of nitric oxide for inhalation on the number of intensive care unit (ICU) and total hospital days from date of surgery to discharge date. - to assess the effect of nitric oxide for inhalation on length of time on mechanical ventilator. - to assess the effect of nitric oxide for inhalation on survival assessed at 28 days. - to assess the effect of nitric oxide for inhalation on the usage blood products. - to assess need for renal replacement therapies (hemodialysis, artrio-venous or veno-venous hemofiltration) by day 28. -to assess number of patients requiring right ventricular assist device by day 28. ; Primary end point(s): The primary endpoint for this study will be the number of patients meeting failure criteria within 48 hours on study drug as defined by either 2 or more of the following, sustained for 15 minutes after complete removal from CPB support: - Left ventricular Flow Rate Index (LVFRI) = 2.0 L/min/m2. - 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. | — |
Countries
Germany, United Kingdom
Outcome results
None listed