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

NCT03081052 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 519

Last updated 2023-02-16

Study results available
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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.

Conditions

  • Heart Transplant Surgery
  • Lung Transplant Surgery

Interventions

DRUG

iNO

Subject will receive inhaled Nitric Oxide in this intervention

DRUG

iEPO

Subject will receive inhaled Epoprostrenol in this intervention

Sponsors & Collaborators

Principal Investigators

  • Kamrouz Ghadimi, MD · Duke Health

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-04
Primary Completion
2020-10-05
Completion
2021-09-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03081052 on ClinicalTrials.gov