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OpenTrials
Completed

NCT Number: NCT03081052

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

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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Key information

Conditions

Heart Transplant Surgery Lung Transplant Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Duke Health

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iNO

Drug

Subject will receive inhaled Nitric Oxide in this intervention

Other names: Inhaled Nitric Oxide

iEPO

Drug

Subject will receive inhaled Epoprostrenol in this intervention

Other names: Inhaled Epoprostrenol

Primary outcomes

  1. Number of Participants With Grade 3 Primary Graft Dysfunction (PGD) for Lung Transplant Subjects

    Time frame: Up to 72 hours

    This is defined by the International Society of Heart and Lung Transplantation (ISHLT) as severe hypoxemia with a PaO2-to-FiO2 ratio < 200 or the presence of venovenous extracorporeal membrane oxygenation (VV ECMO) at a time-point within the first 72 hours after lung transplantation.

  2. Number of Participants With Moderate or Severe RV Failure for the LVAD Implantation Subjects and Severe RV Failure for Heart Transplantation Subjects

    Time frame: up to approximately 21 days after LVAD placement, up to approximately 30 days after heart transplantation

    This is defined by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) score of moderate or severe right-heart failure for LVADS, and by the incidence of an RVAD placement or ECMO for RHF for heart transplants.

Secondary outcomes

  1. Duration of Postoperative Mechanical Ventilation

    Time frame: up to approximately 90 days after index surgery

    Length of time from intubation until patient is extubated

  2. Per Patient Inhaled Pulmonary Vasodilator (iPVD) Cost

    Time frame: up to approximately 30 days after index surgery

    Data reflects a per patient cost in dollars that has been scaled to a unit of measure relative to the cost per hour of drug and multiplied by the duration of iPVD administration. In our study, iNO cost 7 times that of iEPO per hour, hence for each patient this outcome value is the duration of iPVD administration multiplied by 7 if a patient is randomized to iNO or multiplied by 1 if randomized to iEPO.

  3. Length of ICU Stay

    Time frame: up to approximately 90 days after index surgery

    Length of time from ICU admission from surgery until ICU discharge

  4. Length of Hospital Stay

    Time frame: up to approximately 1 year after index surgery

    Length of time from surgery to hospital discharge

  5. Number of Participants With Acute Kidney Injury

    Time frame: up to approximately 14 days

    defined by Modified KDIGO-AKI definition:

    • Increase in Serum Creatinine (Cr) by ≥0.3mg/dL within 48 hours; or
    • Increase in Cr to ≥1.5 times baseline
    • Urine output is not included as urine could be under-captured after Foley catheter removal

  6. Number of Participants With In-hospital Mortality

    Time frame: up to approximately 1 year after index surgery

    Death that occurs during the hospital stay

  7. Number of Participants With Post-operative Mortality Within 30 Days

    Time frame: up to approximately 30 days after index surgery

    From the day of surgery to 30 days postoperatively.

  8. Number of Participants With Post-operative Mortality Within 90 Days

    Time frame: up to approximately 90 days after index surgery

    From the day of surgery to 90 days after index surgery

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Acronym: INSPIRE-FLO

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Mar 15, 2017
Registry last updated
Feb 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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