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

NCT03081052 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Pro00078035
• Study Type: interventional
• Target: 519
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplant Surgery; Lung Transplant Surgery

Keywords

Heart and Lung transplantation surgery; Pulmonary vasodilation therapy

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• 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

Study Arms (4)

Lung transplant with iNO

ACTIVE COMPARATOR

Drug: iNO

Lung transplant with iEPO

ACTIVE COMPARATOR

Drug: iEPO

Heart transplant & LVAD implantation with iNO

ACTIVE COMPARATOR

Drug: iNO

Heart transplant & LVAD implantation with iEPO

ACTIVE COMPARATOR

Drug: iEPO

Interventions

iNO DRUG

Subject will receive inhaled Nitric Oxide in this intervention

Also known as: Inhaled Nitric Oxide

Heart transplant & LVAD implantation with iNO; Lung transplant with iNO

iEPO DRUG

Subject will receive inhaled Epoprostrenol in this intervention

Also known as: Inhaled Epoprostrenol

Heart transplant & LVAD implantation with iEPO; Lung transplant with iEPO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Heart transplantation
• LVAD placement
• Lung Transplantation

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Health

Durham, North Carolina, 27710, United States

Location

Related Publications (2)

• 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.

  PMID: 37401479 DERIVED

• 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.

  PMID: 34787647 DERIVED

Results Point of Contact

• Title: Kamrouz Ghadimi, M.D., M.H.Sc.
• Organization: Duke University

kamrouz.ghadimi@duke.edu

919-681-6532

Study Officials

• Kamrouz Ghadimi, MD

  Duke Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 15, 2017
• Study Start: May 4, 2017
• Primary Completion: October 5, 2020
• Study Completion: September 5, 2021
• Last Updated: February 16, 2023
• Results First Posted: March 10, 2022

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)