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Clinical trial

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

ID
Name
Pro00078035
Description
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.
Trial arms
Trial start
2017-05-04
Estimated PCD
2020-10-05
Trial end
2021-09-05
Status
Completed
Phase
Early phase I
Treatment
iNO
Subject will receive inhaled Nitric Oxide in this intervention
Arms:
Heart transplant & LVAD implantation with iNO, Lung transplant with iNO
Other names:
Inhaled Nitric Oxide
iEPO
Subject will receive inhaled Epoprostrenol in this intervention
Arms:
Heart transplant & LVAD implantation with iEPO, Lung transplant with iEPO
Other names:
Inhaled Epoprostrenol
Size
519
Primary endpoint
Number of Participants With Grade 3 Primary Graft Dysfunction (PGD) for Lung Transplant Subjects
Up to 72 hours
Number of Participants With Moderate or Severe RV Failure for the LVAD Implantation Subjects and Severe RV Failure for Heart Transplantation Subjects
up to approximately 21 days after LVAD placement, up to approximately 30 days after heart transplantation
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 519, 'type': 'ACTUAL'}}
Updated at
2023-02-16

1 organization

2 products

2 indications

Organization
Duke University
Product
iNO
Indication
Heart Transplant Surgery
Indication
Lung Transplant Surgery
Product
iEPO