Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
| Status: | Recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/2/2019 |
| Start Date: | May 4, 2017 |
| End Date: | May 2021 |
| Contact: | Tiffany L Bisanar, RN, BSN |
| Email: | tiffany.bisanar@duke.edu |
| Phone: | 919-681-0866 |
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.
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.
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.
424 informed and consented 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.
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.
424 informed and consented 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.
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
- 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
We found this trial at
1
site
Durham, North Carolina 27710
Principal Investigator: Kamrouz Ghadimi, MD
Phone: 919-681-0866
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