Phase 4
Completed N=432
Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
Heart Transplant Surgery · Lung Transplant Surgery
Source: ClinicalTrials.gov NCT03081052 ↗
Enrolled (actual)
432
Serious AEs
11.6%
Results posted
Mar 2022
Primary outcomePrimary: Number of Participants With Grade 3 Primary Graft Dysfunction (PGD) for Lung Transplant Subjects — 39; 46 Participants — p=0.019
◆ Published Evidence
Established
29citations · ~10 / year
Inhaled Epoprostenol Compared With Nitric Oxide for Right Ventricular Support After Major Cardiac Surgery.
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.
Linked Publications (2)
-
Inhaled Epoprostenol Compared With Nitric Oxide for Right Ventricular Support After Major Cardiac Surgery.
-
Inhaled Pulmonary Vasodilator Therapy in Adult Lung Transplant: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Grade 3 Primary Graft Dysfunction (PGD) for Lung Transplant Subjects |
39; 46 | 0.019 sig |
| PRIMARY Number of Participants With Moderate or Severe RV Failure for the LVAD Implantation Subjects and Severe RV Failure for Heart Transplantation Subjects |
25; 30 | 0.012 sig |
| SECONDARY Duration of Postoperative Mechanical Ventilation |
17; 18; 26; 24 | 0.747 |
| SECONDARY Per Patient Inhaled Pulmonary Vasodilator (iPVD) Cost |
544; 70; 772; 114 | — |
| SECONDARY Length of ICU Stay |
4; 4; 6; 6 | 0.453 |
| SECONDARY Length of Hospital Stay |
23; 23; 16; 17 | 0.864 |
| SECONDARY Number of Participants With Acute Kidney Injury |
72; 68; 96; 101 | 0.251 |
| SECONDARY Number of Participants With In-hospital Mortality |
5; 7; 6; 11 | — |
| SECONDARY Number of Participants With Post-operative Mortality Within 30 Days |
2; 1; 4; 7 | 0.614 |
| SECONDARY Number of Participants With Post-operative Mortality Within 90 Days |
4; 4; 5; 12 | — |
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
Data sourced from ClinicalTrials.gov (NCT03081052) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.