Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes

• Status: Active, not recruiting
• Trial end date: 2021-10-05
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Nitric Oxide; Vasodilator Agents

Criteria

Inclusion Criteria:

• Heart transplantation

• LVAD placement

• Lung Transplantation

Exclusion Criteria:

• 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