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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

519 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-04

Study Completion Date

2021-09-05

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Transplant Surgery Lung Transplant Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Subject will receive inhaled Nitric Oxide in this intervention

Intervention Type DRUG

iEPO

Subject will receive inhaled Epoprostrenol in this intervention

Intervention Type DRUG

Other Intervention Names

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Inhaled Nitric Oxide Inhaled Epoprostrenol

Eligibility Criteria

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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)

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No