E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
acute right ventricular failure |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10063082 |
E.1.2 | Term | Acute right ventricular failure |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- 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
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E.2.2 | Secondary objectives of the trial |
- 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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 10E 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 at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considered ‘failure to wean’. - Death.
CPB- Cardiopulmonary Bypass
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Day 28 of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |