Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
Completed · Phase 4
Conditions studied: Heart Transplant Surgery, Lung Transplant Surgery
In brief
1\. 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.
Key facts
- Study ID
- NCT03081052
- Run by
- Duke University
- People needed
- 519
- Starts
- 2017-05-04
- Expected to finish
- 2021-09-05
- Last updated by the study team
- 2023-02-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Heart transplantation
- LVAD placement
- Lung Transplantation
You may not qualify if…
- 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
Where it is running
- Duke Health — Durham, North Carolina, United States
Full record on ClinicalTrials.gov
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