EUCTR2005-000326-24-GB进行中（未招募）1 期
The Effects of Nitric Oxide for Inhalation during Left Ventricular Assist Device (LVAD) Implantation. - INOT41
INO Therapeutics0 个研究点目标入组 110 人开始时间: 2005年6月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •- 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.
研究者
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