Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 519
- 试验地点
- 1
- 主要终点
- Number of Participants With Moderate or Severe RV Failure for the LVAD Implantation Subjects and Severe RV Failure for Heart Transplantation Subjects
研究概览
简要总结
- to conduct a clinical investigation to determine if inhaled epoprostenol (Veletri®, iEPO) and inhaled nitric oxide (iNO) will have similar impact on outcomes in adult patients undergoing durable LVAD placement, heart transplantation, or lung transplantation 2. to conduct a cost-capture analysis on the expense each drug incurs per patient.
详细描述
In adult cardiothoracic surgical patients, iNO is used to treat precapillary pulmonary hypertension (PH), right-sided heart failure (RHF), and ventilation-to-perfusion (V:Q) mismatch. Adult patients who undergo durable LVAD implantation (e.g. Heartware®, Heartmate 2®, or Heartmate 3®), cardiac transplantation for HFrEF, or those that have endured lung transplantation as a result of end-stage lung disease, compose the largest subpopulation which receives iPVD therapy at Duke University Hospital. iEPO may display an equivalent efficacy profile to iNO for pulmonary vasodilation and oxygenation and have a similar impact on clinical outcomes.
Subjects undergoing LVAD placement or heart transplantation (N=224) or lung transplantation (N=200) will be prospectively enrolled over a three-year period (one-year for follow-up). Patients will be randomly assigned 1:1 according to stratified randomization blocking either iNO or iEPO. Additional study procedures will involve data collection, blood, and tissue sampling.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart transplantation
- •LVAD placement
- •Lung Transplantation
排除标准
- •Combined Organ Transplantation
- •Age < 18 years old
- •Pregnancy
- •Known allergy to prostaglandin (rare)
- •Refusal of blood products due to personal or religious preference
- •Subject is enrolled in another study protocol, which does not allow randomization of PVD therapy
- •Heart transplant or durable LVAD recipients with adult congenital heart disease (CHD)
- •o Caveat: Does NOT meet exclusion criteria if the scheduled heart transplant or LVAD implantation is due to heart failure from a previous heart transplantation related to CHD, performed more than 90 days previous to the date of trial enrollment
- •Heart transplant recipients diagnosed with Arrythmogenic Right Ventricular Cardiomyopathy
- •Heart transplant recipients diagnosed with Acute Cardiac Allograft Rejection after a previous heart transplantation.
- •Heart transplant or durable LVAD recipients with preoperative RVAD for right heart failure
- •Patient is scheduled to undergo lung transplantation but has undergone heart transplantation in the previous 90 days
- •Patient is scheduled to undergo durable LVAD implantation but has undergone heart transplantation in the previous 90 days
- •Patient is scheduled to undergo heart transplantation but has undergone lung transplantation in the previous 90 days
- •Patients with preoperative Venovenous ECMO as a bridge to lung transplantation
- •Heart transplant or durable LVAD recipients with preoperative RVAD for right heart failure
研究组 & 干预措施
Lung transplant with iNO
干预措施: iNO (Drug)
Lung transplant with iEPO
干预措施: iEPO (Drug)
Heart transplant & LVAD implantation with iNO
干预措施: iNO (Drug)
Heart transplant & LVAD implantation with iEPO
干预措施: iEPO (Drug)
结局指标
主要结局
Number of Participants With Moderate or Severe RV Failure for the LVAD Implantation Subjects and Severe RV Failure for Heart Transplantation Subjects
时间窗: up to approximately 21 days after LVAD placement, up to approximately 30 days after heart transplantation
This is defined by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score of moderate or severe right-heart failure for LVADS, and by the incidence of an RVAD placement or ECMO for RHF for heart transplants.
Number of Participants With Grade 3 Primary Graft Dysfunction (PGD) for Lung Transplant Subjects
时间窗: Up to 72 hours
This is defined by the International Society of Heart and Lung Transplantation (ISHLT) as severe hypoxemia with a PaO2-to-FiO2 ratio \< 200 or the presence of venovenous extracorporeal membrane oxygenation (VV ECMO) at a time-point within the first 72 hours after lung transplantation.
次要结局
- Number of Participants With In-hospital Mortality(up to approximately 1 year after index surgery)
- Length of ICU Stay(up to approximately 90 days after index surgery)
- Per Patient Inhaled Pulmonary Vasodilator (iPVD) Cost(up to approximately 30 days after index surgery)
- Duration of Postoperative Mechanical Ventilation(up to approximately 90 days after index surgery)
- Length of Hospital Stay(up to approximately 1 year after index surgery)
- Number of Participants With Acute Kidney Injury(up to approximately 14 days)
- Number of Participants With Post-operative Mortality Within 30 Days(up to approximately 30 days after index surgery)
- Number of Participants With Post-operative Mortality Within 90 Days(up to approximately 90 days after index surgery)