Phase 4 N=432 Randomized Triple-blind Other

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

Heart Transplant Surgery · Lung Transplant Surgery

Bottom Line

View on ClinicalTrials.gov: NCT03081052 ↗

Enrolled (actual)

432

Serious AEs

11.6%

Results posted

Mar 2022

Primary outcome: Primary: Number of Participants With Grade 3 Primary Graft Dysfunction (PGD) for Lung Transplant Subjects — 39; 46 Participants — p=0.019

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: iNO (Drug); iEPO (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Oct 2020

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	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03081052). 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.