Extracorporeal Photopheresis and Early Cardiac Graft Vasculopathy

NCT04226521 | Completed

• 1 other identifier: ECP-OCT2019
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Heart transplantation is a golden standard for the treatment of terminal heart failure. The major cause of death in late posttransplant period is cardiac allograft vasculopathy (CAV). This posttransplant complication develops slowly over several years, and when diagnosed either by conventional coronary angiography or due to graft failure, it is often too advanced and difficult to treat since it is diffuse coronary artery disease. Therefore, early prevention of CAV is a subject of major interest in the transplant cardiology. Since CAV is associated with immune factors, immunomodulatory therapeutic options, like extracorporeal photopheresis are lately being investigated. Unlike conventional coronary angiography, optical coherence tomography (OCT) is able to detect the development of CAV in the earliest phase, i.e. even in the first post-transplant year. In our study, we plan to investigate the prophylactic effect of extracorporeal photopheresis in the early development of cardiac graft vasculopathy detected by OCT.

Conditions

Cardiac Allograft Vasculopathy; Heart Transplant Rejection

Keywords

Heart transplant; vasculopathy; extracorporeal photopheresis; prevention; optical coherence tomography

Outcome Measures

Primary Outcomes (1)

• Prevention of cardiac allograft vasculopathy detected by optical coherence tomography

  It will be measured as the mean change in maximal intimal thickness (mm) between matched slices and the mean change in intimal volume (mm3) between matched coronary segments from baseline to month 12. Intima-to-media border will be identified as sharp line between first bright layer (intima) and first dark layer (media) of vessel wall. OCT will be performed during the patient's angiogram at baseline (1-3 months after transplantation) and again at one year after transplantation. An attempt will be made to get OCT image of all three coronary arteries. Two independent experienced angiographers, who will be blinded to clinical data, will review the baseline and follow-up image acquisition sequences to accurately match the coronary segments. We will compare the mean change of maximal intimal thickness (mm) and/or the mean change of intimal volume (mm3) between patients who underwent extracorporeal photopheresis (ECP) to those who did not undergo ECP.

  One year

Secondary Outcomes (7)

• Number of patients with angiographically detected coronary artery disease

  1 year

• Number of patients with acute cellular rejection

  1 year

• Number of patients with antibody-mediated rejection

  1 year

• Number of patients with positive donor specific antibodies

  1 year

• Left ventricular function expressed as ejection fraction (%) and plasma levels of NT-proBNP

  1 year

Study Arms (2)

Photopheresis

EXPERIMENTAL

Patients who sign informed consent form undergo prophylactic extracorporeal photopheresis after heart transplant according to predetermined protocol

Procedure: Extracoropreal photopheresis

No prophylactic photopheresis

NO INTERVENTION

Standard post-transplant protocol without prophylactic extracorporeal photopheresis

Interventions

Extracoropreal photopheresis PROCEDURE

Patients who sign informed consent form undergo prophylactic extracorporeal photopheresis after heart transplant according to predetermined protocol

Photopheresis

Eligibility Criteria

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

You may qualify if:

• age \>18 and \<65
• primary orthotopic heart transplant
• early photopheresis
• adequate intravenous approach
• signed informed consent

You may not qualify if:

• aphakia
• psoralen hypersensitivity
• active retinal disease - photosensitive diseases
• splenectomy
• L \<2000; Hb \<70 g/L
• coagulopathy

Sponsors & Collaborators

• Bosko Skoric: lead
• University of Zagreb: collaborator

Study Sites (1)

UHC Zagreb

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Boško Skorić

  UHC Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asst. prof.

Model Details: Patients are randomized after heart transplant into two groups. Those randomized for extracorporeal photopheresis undergo 10 procedures during first year, in addition to standard follow-up. Patients in the control group are treated and followed-up according to standard protocol of our transplant center.

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: January 13, 2020
• Study Start: January 1, 2018
• Primary Completion: October 17, 2023
• Study Completion: October 17, 2023
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: The data will be available in 2 years for time frame of 5 years

Locations

CR (1)