Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03081052
Recruitment Status : Active, not recruiting
First Posted : March 15, 2017
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date  ICMJE March 8, 2017
First Posted Date  ICMJE March 15, 2017
Last Update Posted Date November 6, 2020
Actual Study Start Date  ICMJE May 4, 2017
Actual Primary Completion Date October 5, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2017)
  • Duration of postoperative mechanical ventilation [ Time Frame: up to approximately 90 days ]
    Length of time from intubation until patient is extubated
  • Per patient cost [ Time Frame: up to approximately 30 days ]
    Cost associated with the duration of PVD administration
  • Length of ICU stay [ Time Frame: up to approximately 90 days ]
    Length of time from ICU admission from surgery until ICU discharge
  • Length of hospital stay [ Time Frame: up to approximately 1 year ]
    Length of time from surgery to hospital discharge
  • Incidence of Acute Kidney Injury [ Time Frame: up to approximately 14 days ]
    defined by KDIGO-AKI criteria
  • Incidence of in-hospital mortality [ Time Frame: up to approximately 1 year ]
    Death that occurs during the hospital stay
  • Incidence of postoperative mortality within 30 days [ Time Frame: up to approximately 30 days ]
    From the day of surgery to 30 days (+/- 3 days)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
Official Title  ICMJE Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE
  • Heart Transplant Surgery
  • Lung Transplant Surgery
Intervention  ICMJE
  • Drug: iNO
    Subject will receive inhaled Nitric Oxide in this intervention
    Other Name: Inhaled Nitric Oxide
  • Drug: iEPO
    Subject will receive inhaled Epoprostrenol in this intervention
    Other Name: Inhaled Epoprostrenol
Study Arms  ICMJE
  • Active Comparator: Lung transplant with iNO
    Intervention: Drug: iNO
  • Active Comparator: Lung transplant with iEPO
    Intervention: Drug: iEPO
  • Active Comparator: Heart transplant & LVAD implantation with iNO
    Intervention: Drug: iNO
  • Active Comparator: Heart transplant & LVAD implantation with iEPO
    Intervention: Drug: iEPO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2017)
424
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 5, 2021
Actual Primary Completion Date October 5, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03081052
Other Study ID Numbers  ICMJE Pro00078035
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kamrouz Ghadimi, MD Duke University Health System
PRS Account Duke University
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP