NCT03081052|CompletedPhase 4ResultsFDA Drug
Inhaled Selective Pulmonary Vasodilators for Advanced Heart Failure Therapies and Lung Transplantation Outcomes
INSPIRE-FLO
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Sponsor study identifier
interventional
519
1 country
1
Study Start
May 4, 2017
Actual (reported)Primary Completion
October 5, 2020
Actual (reported)Study Completion
September 5, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 5, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2017
Actual (reported)March 15, 2017
Actual (reported)May 4, 2017
Actual (reported)October 5, 2020
Actual (reported)September 5, 2021
Actual (reported)March 10, 2022
Actual (reported)Number of Participants With Grade 3 Primary Graft Dysfunction (PGD) for Lung Transplant Subjects
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.
Up to 72 hours
Number of Participants With Moderate or Severe RV Failure for the LVAD Implantation Subjects and Severe RV Failure for Heart Transplantation Subjects
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.
up to approximately 21 days after LVAD placement, up to approximately 30 days after heart transplantation
Duration of Postoperative Mechanical Ventilation
up to approximately 90 days after index surgery
Per Patient Inhaled Pulmonary Vasodilator (iPVD) Cost
up to approximately 30 days after index surgery
Length of ICU Stay
up to approximately 90 days after index surgery
Length of Hospital Stay
up to approximately 1 year after index surgery
Number of Participants With Acute Kidney Injury
up to approximately 14 days
Subject will receive inhaled Nitric Oxide in this intervention
Subject will receive inhaled Epoprostrenol in this intervention
Duke Health
Durham, North Carolina, 27710, United States
Ghadimi K, Cappiello JL, Wright MC, Levy JH, Bryner BS, DeVore AD, Schroder JN, Patel CB, Rajagopal S, Shah SH, Milano CA; INSPIRE-FLO Investigators. Inhaled Epoprostenol Compared With Nitric Oxide for Right Ventricular Support After Major Cardiac Surgery. Circulation. 2023 Oct 24;148(17):1316-1329. doi: 10.1161/CIRCULATIONAHA.122.062464. Epub 2023 Jul 4.
Ghadimi K, Cappiello J, Cooter-Wright M, Haney JC, Reynolds JM, Bottiger BA, Klapper JA, Levy JH, Hartwig MG; INSPIRE-FLO Investigators. Inhaled Pulmonary Vasodilator Therapy in Adult Lung Transplant: A Randomized Clinical Trial. JAMA Surg. 2022 Jan 1;157(1):e215856. doi: 10.1001/jamasurg.2021.5856. Epub 2022 Jan 12.
Kamrouz Ghadimi, MD
Duke Health
519 participants (actual enrollment reported by the registry).
First Submitted
March 8, 2017
First Posted
March 15, 2017
Study Start
May 4, 2017
Actual (reported)Follow-Up at 6 Years of a Cohort of Children Born Very Prematurely
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 5, 2020
Actual (reported)Study Completion
September 5, 2021
Actual (reported)Last Updated
February 16, 2023
Results First Posted
March 10, 2022
Record last verified: 2023-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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