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Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes (INSPIRE-FLO)

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ClinicalTrials.gov Identifier: NCT03081052
Recruitment Status : Recruiting
First Posted : March 15, 2017
Last Update Posted : May 9, 2019
Sponsor:
Information provided by (Responsible Party):
Duke University

Brief 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.

Condition or disease Intervention/treatment Phase
Heart Transplant Surgery Lung Transplant Surgery Drug: iNO Drug: iEPO Phase 4

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 424 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
Actual Study Start Date : May 4, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lung transplant with iNO Drug: iNO
Subject will receive inhaled Nitric Oxide in this intervention
Other Name: Inhaled Nitric Oxide

Active Comparator: Lung transplant with iEPO Drug: iEPO
Subject will receive inhaled Epoprostrenol in this intervention
Other Name: Inhaled Epoprostrenol

Active Comparator: Heart transplant & LVAD implantation with iNO Drug: iNO
Subject will receive inhaled Nitric Oxide in this intervention
Other Name: Inhaled Nitric Oxide

Active Comparator: Heart transplant & LVAD implantation with iEPO Drug: iEPO
Subject will receive inhaled Epoprostrenol in this intervention
Other Name: Inhaled Epoprostrenol




Primary Outcome Measures :
  1. Incidence of 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 an time-point within the first 72 hours after lung transplantation.

  2. Incidence of moderate or severe RV failure for the LVAD implantation subjects. [ Time Frame: up to approximately 21 days after LVAD placement ]
    This is defined by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) scoring.

  3. Incidence of severe RV failure for Heart Transplantation subjects. [ Time Frame: up to approximately 30 days after heart transplantation ]
    This is defined by the incidence of an RVAD placement


Secondary Outcome Measures :
  1. Duration of postoperative mechanical ventilation [ Time Frame: up to approximately 90 days ]
    Length of time from intubation until patient is extubated

  2. Per patient cost [ Time Frame: up to approximately 30 days ]
    Cost associated with the duration of PVD administration

  3. Length of ICU stay [ Time Frame: up to approximately 90 days ]
    Length of time from ICU admission from surgery until ICU discharge

  4. Length of hospital stay [ Time Frame: up to approximately 1 year ]
    Length of time from surgery to hospital discharge

  5. Incidence of Acute Kidney Injury [ Time Frame: up to approximately 14 days ]
    defined by KDIGO-AKI criteria

  6. Incidence of in-hospital mortality [ Time Frame: up to approximately 1 year ]
    Death that occurs during the hospital stay

  7. Incidence of postoperative mortality within 30 days [ Time Frame: up to approximately 30 days ]
    From the day of surgery to 30 days (+/- 3 days)

  8. Incidence of post-operative mortality within 90 days [ Time Frame: up to approximately 90 days ]
    From the day of surgery to 90 days (+/- 5 days)

  9. Incidence of post-operative mortality within 1 year [ Time Frame: up to approximately 1 year ]
    From the day of surgery to 1 year (+/- 7 days)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03081052


Contacts
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Contact: Tiffany L Bisanar, RN, BSN 919-681-0866 tiffany.bisanar@duke.edu
Contact: Kamrouz Ghadimi, MD

Locations
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United States, North Carolina
Duke Health Recruiting
Durham, North Carolina, United States, 27710
Contact: Tiffany L Bisanar, RN, BSN    919-681-0866    tiffany.bisanar@duke.edu   
Principal Investigator: Kamrouz Ghadimi, MD         
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Kamrouz Ghadimi, MD Duke University Health System

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03081052     History of Changes
Other Study ID Numbers: Pro00078035
First Posted: March 15, 2017    Key Record Dates
Last Update Posted: May 9, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Duke University:
Heart and Lung transplantation surgery
Pulmonary vasodilation therapy
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases
Nitric Oxide
Vasodilator Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Gasotransmitters
Protective Agents